None listed
Conditions
Interventions
Test group and control group:dose
Sponsors
Phase I Clinical Study Institution, The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 60 years old male or female (1:1 M/F); 2) patient is undergoing routine gastroscopy; 3) the ASA score ranged from I to II; 4) body mass index (BMI) between 19.0 and 30.0 kg/m2; 5) To be able to good communication with researchers, and signed a written informed consent.;Inclusion criteria: 1) Aged 18 to 60 years old male or female (1:1 M/F); 2) patient is undergoing routine gastroscopy; 3) the ASA score ranged from I to II; 4) body mass index (BMI) between 19.0 and 30.0 kg/m2; 5) To be able to good communication with researchers, and signed a written informed consent.;Inclusion criteria: 1) Aged 18 to 60 years old male or female (1:1 M/F); 2) patient is undergoing routine gastroscopy; 3) the ASA score ranged from I to II; 4) body mass index (BMI) between 19.0 and 30.0 kg/m2; 5) To be able to good communication with researchers, and signed a written informed consent.;Inclusion criteria: 1) Aged 18 to 60 years old male or female (1:1 M/F); 2) patient is undergoing routine gastroscopy; 3) the ASA score ranged from I to II; 4) body mass index (BMI) between 19.0 and 30.0 kg/m2; 5) To be able to good communication with researchers, and signed a written informed consent.;Inclusion criteria: 1) Aged 18 to 60 years old male or female (1:1 M/F); 2) patient is undergoing routine gastroscopy; 3) the ASA score ranged from I to II; 4) body mass index (BMI) between 19.0 and 30.0 kg/m2; 5) To be able to good communication with researchers, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1) patients with contraindications to general anesthesia; 2) allergic to ketamine hydrochloride, lidocaine, esmolol, ketamine, propofol, opioids, ondansetron, neostigmine,and for patients who are intolerant of belladonna alkaloids; 3) the need for complex endoscopic diagnosis and treatment techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, endoscopic endoscopic muscle resection, etc.); 4) the patient who is going to accept intubation operation; 5) suspected gastric and duodenal outflow obstruction associated with retention of contents; 6) patients is suspected with upper gastrointestinal bleeding; 7) complicated with severe respiratory disease (obstructive sleep apnea syndrome, mouth, neck activity disorder or mandibular limited, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma); 8) the vital signs examination, the 12 lead electrocardiogram and the clinical laboratory examination (blood routine, urine routine, blood biochemistry and blood coagulation function) in the screening period before the test, the results were judged by clinicians to be abnormal and clinically significant; 9) hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti -HCV), human immunodeficiency virus antibody (anti -HIV), Treponema pallidum antibody (anti -TP) tests showed positive; 10) abnormal lipid metabolism, including primary hyperlipidemia, diabetes mellitus, hyperlipidemia and pancreatitis; 11) patients who were identified as having difficulty with airway management (modified Markov grade IV); 12) pregnant test has a postive result woman; 13) traumatic brain injury, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, and patients with central nervous system diseases; 14) patient with a history of hyperthyroidism; 15) elevated intraocular pressure (such as glaucoma) or penetrating eye injuries; 16) with mental disorders (schizophrenia, bipolar disorder, bipolar disorder, psychosis) history and history of drug and patients with cognitive impairment; 17) patients with asthma history; 18) smokers who smoked more than 10 cigarettes or equivalent within 1 months before the test (3 months before the trial) and were unable to quit smoking during the test period; 19) with a history of drug abuse and / or alcohol abuse within the first 3 months of the screen; alcoholism was an average daily drinking of more than 2 units of alcohol (1 units =360 mL or 45 mL alcohol, 40% white wines or 150 mL wines); 20) test in the 14 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitro imidazole, sedatives, Vera Pammy, fluoroquinolones, antihistamines and herbal medicines, etc.); 21) enrolled in other drug trials in the first 3 months; 22) other researchers considered unsuitable for entry into the group.;Exclusion criteria: 1) patients with contraindications to general anesthesia; 2) allergic to ketamine hydrochloride, lidocaine, esmolol, ketamine, propofol, opioids, ondansetron, neostigmine,and for patients who are intolerant of belladonna alkaloids; 3) the need for complex endoscopic diagnosis and treatment techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, endoscopic endoscopic muscle resection, etc.); 4) the patient who is going to accept intubation operation; 5) suspected gastric and duodenal outflow obstruction associated with retention of contents; 6) patients is suspected with upper gastrointestinal bleeding; 7) complicated with severe respiratory disease (obstructive sleep apnea syndrome, mouth, neck activity disorder or mandibular limited, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma); 8) the vital signs examination, the 12 lead electrocardiogram and the clinical laboratory examination (blood routine, urine routine, blood biochemistry and blood coagulation function) in the screening period before the test, the results were judged by clinicians to be abnormal and clinically significant; 9) hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti -HCV), human immunodeficiency virus antibody (anti -HIV), Treponema pallidum antibody (anti -TP) tests showed positive; 10) abnormal lipid metabolism, including primary hyperlipidemia, diabetes mellitus, hyperlipidemia and pancreatitis; 11) patients who were identified as having difficulty with airway management (modified Markov grade IV); 12) pregnant test has a postive result woman; 13) traumatic brain injury, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, and patients with central nervous system diseases; 14) patient with a history of hyperthyroidism; 15) elevated intraocular pressure (such as glaucoma) or penetrating eye injuries; 16) with mental disorders (schizophrenia, bipolar disorder, bipolar disorder, psychosis) history and history of drug and patients with cognitive impairment; 17) patients with asthma history; 18) smokers who smoked more than 10 cigarettes or equivalent within 1 months before the test (3 months before the trial) and were unable to quit smoking during the test period; 19) with a history of drug abuse and / or alcohol abuse within the first 3 months of the screen; alcoholism was an average daily drinking of more than 2 units of alcohol (1 units =360 mL or 45 mL alcohol, 40% white wines or 150 mL wines); 20) test in the 14 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitro imidazole, sedatives, Vera Pammy, fluoroquinolones, antihistamines and herbal medicines, etc.); 21) enrolled in other drug trials in the first 3 months; 22) other researchers considered unsuitable for entry into the group.;Exclusion criteria: 1) patients with contraindications to general anesthesia; 2) allergic to ketamine hydrochloride, lidocaine, esmolol, ketamine, propofol, opioids, ondansetron, neostigmine,and for patients who are intolerant of belladonna alkaloids; 3) the need for complex endoscopic diagnosis and treatment techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, endoscopic endoscopic muscle resection, etc.); 4) the patient who is going to accept intubation operation; 5) suspected gastric and duodenal outflow obstruction associated with retention of contents; 6) patients is suspected with upper gastrointestinal bleeding; 7) complicated with severe respiratory disease (obstructive sleep apnea syndrome, mouth, neck activity disorder or mandibular limited, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma); 8) the vital signs examination, the 12 lead electrocardiogram and the clinical laboratory examination (blood routine, urine routine, blood biochemistry and blood coagulation function) in the screening period before the test, the results were judged by clinicians to be abnormal and clinically significant; 9) hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti -HCV), human immunodeficiency virus antibody (anti -HIV), Treponema pallidum antibody (anti -TP) tests showed positive; 10) abnormal lipid metabolism, including primary hyperlipidemia, diabetes mellitus, hyperlipidemia and pancreatitis; 11) patients who were identified as having difficulty with airway management (modified Markov grade IV); 12) pregnant test has a postive result woman; 13) traumatic brain injury, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, and patients with central nervous system diseases; 14) patient with a history of hyperthyroidism; 15) elevated intraocular pressure (such as glaucoma) or penetrating eye injuries; 16) with mental disorders (schizophrenia, bipolar disorder, bipolar disorder, psychosis) history and history of drug and patients with cognitive impairment; 17) patients with asthma history; 18) smokers who smoked more than 10 cigarettes or equivalent within 1 months before the test (3 months before the trial) and were unable to quit smoking during the test period; 19) with a history of drug abuse and / or alcohol abuse within the first 3 months of the screen; alcoholism was an average daily drinking of more than 2 units of alcohol (1 units =360 mL or 45 mL alcohol, 40% white wines or 150 mL wines); 20) test in the 14 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitro imidazole, sedatives, Vera Pammy, fluoroquinolones, antihistamines and herbal medicines, etc.); 21) enrolled in other drug trials in the first 3 months; 22) other researchers considered unsuitable for entry into the group.;Exclusion criteria: 1) patients with contraindications to general anesthesia; 2) allergic to ketamine hydrochloride, lidocaine, esmolol, ketamine, propofol, opioids, ondansetron, neostigmine,and for patients who are intolerant of belladonna alkaloids; 3) the need for complex endoscopic diagnosis and treatment techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, endoscopic endoscopic muscle resection, etc.); 4) the patient who is going to accept intubation operation; 5) suspected gastric and duodenal outflow obstruction associated with retention of contents; 6) patients is suspected with upper gastrointestinal bleeding; 7) complicated with severe respiratory disease (obstructive sleep apnea syndrome, mouth, neck activity disorder or mandibular limited, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma); 8) the vital signs examination, the 12 lead electrocardiogram and the clinical laboratory examination (blood routine, urine routine, blood biochemistry and blood coagulation function) in the screening period before the test, the results were judged by clinicians to be abnormal and clinically significant; 9) hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti -HCV), human immunodeficiency virus antibody (anti -HIV), Treponema pallidum antibody (anti -TP) tests showed positive; 10) abnormal lipid metabolism, including primary hyperlipidemia, diabetes mellitus, hyperlipidemia and pancreatitis; 11) patients who were identified as having difficulty with airway management (modified Markov grade IV); 12) pregnant test has a postive result woman; 13) traumatic brain injury, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, and patients with central nervous system diseases; 14) patient with a history of hyperthyroidism; 15) elevated intraocular pressure (such as glaucoma) or penetrating eye injuries; 16) with mental disorders (schizophrenia, bipolar disorder, bipolar disorder, psychosis) history and history of drug and patients with cognitive impairment; 17) patients with asthma history; 18) smokers who smoked more than 10 cigarettes or equivalent within 1 months before the test (3 months before the trial) and were unable to quit smoking during the test period; 19) with a history of drug abuse and / or alcohol abuse within the first 3 months of the screen; alcoholism was an average daily drinking of more than 2 units of alcohol (1 units =360 mL or 45 mL alcohol, 40% white wines or 150 mL wines); 20) test in the 14 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitro imidazole, sedatives, Vera Pammy, fluoroquinolones, antihistamines and herbal medicines, etc.); 21) enrolled in other drug trials in the first 3 months; 22) other researchers considered unsuitable for entry into the group.;Exclusion criteria: 1) patients with contraindications to general anesthesia; 2) allergic to ketamine hydrochloride, lidocaine, esmolol, ketamine, propofol, opioids, ondansetron, neostigmine,and for patients who are intolerant of belladonna alkaloids; 3) the need for complex endoscopic diagnosis and treatment techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, endoscopic endoscopic muscle resection, etc.); 4) the patient who is going to accept intubation operation; 5) suspected gastric and duodenal outflow obstruction associated with retention of contents; 6) patients is suspected with upper gastrointestinal bleeding; 7) complicated with severe respiratory disease (obstructive sleep apnea syndrome, mouth, neck activity disorder or mandibular limited, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma); 8) the vital signs examination, the 12 lead electrocardiogram and the clinical laboratory examination (blood routine, urine routine, blood biochemistry and blood coagulation function) in the screening period before the test, the results were judged by clinicians to be abnormal and clinically significant; 9) hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti -HCV), human immunodeficiency virus antibody (anti -HIV), Treponema pallidum antibody (anti -TP) tests showed positive; 10) abnormal lipid metabolism, including primary hyperlipidemia, diabetes mellitus, hyperlipidemia and pancreatitis; 11) patients who were identified as having difficulty with airway management (modified Markov grade IV); 12) pregnant test has a postive result woman; 13) traumatic brain injury, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, and patients with central nervous system diseases; 14) patient with a history of hyperthyroidism; 15) elevated intraocular pressure (such as glaucoma) or penetrating eye injuries; 16) with mental disorders (schizophrenia, bipolar disorder, bipolar disorder, psychosis) history and history of drug and patients with cognitive impairment; 17) patients with asthma history; 18) smokers who smoked more than 10 cigarettes or equivalent within 1 months before the test (3 months before the trial) and were unable to quit smoking during the test period; 19) with a history of drug abuse and / or alcohol abuse within the first 3 months of the screen; alcoholism was an average daily drinking of more than 2 units of alcohol (1 units =360 mL or 45 mL alcohol, 40% white wines or 150 mL wines); 20) test in the 14 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitro imidazole, sedatives, Vera Pammy, fluoroquinolones, antihistamines and herbal medicines, etc.); 21) enrolled in other drug trials in the first 3 months; 22) other researchers considered unsuitable for entry into the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| S-ketamine; | — |
Secondary
| Measure | Time frame |
|---|---|
| R-ketamine;R-N- demethylation ketamine;S-N-demethylation ketamine; | — |
Countries
China
Contacts
Public ContactGuoping Yang;Guoping Yang;Guoping Yang;Guoping Yang;Guoping Yang ;;;;
The Third Xiangya Hospital of Central South University ;The Third Xiangya Hospital of Central South University ;The Third Xiangya Hospital of Central South University ;The Third Xiangya Hospital of Central South University ;The Third Xiangya Hospital of Central South University
Outcome results
None listed