Colonoscopy
Conditions
Brief summary
104 patients who undergo painless colonoscopy from Decemenber 1,2019 to June 30,2022 will be randomized to two groups: propofol group and dexmedetomidine group. In the dexmedetomidine group,dexmedetomidine was infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol was administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 during the whole process.
Detailed description
104 patients who undergo painless colonoscopy from Decemenber 1,2019 to June 30,2022 will be randomized to two groups: propofol group and dexmedetomidine group. In the dexmedetomidine group,dexmedetomidine was infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol was administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1.For all patients, if Ramsay sedation scale score reached 3, colonoscope was inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg was administrated as the rescue dose if body movement occurred during colonoscopy The primary outcome was the occurrence of hypotension. Secondary outcomes included the followings:(1) the duration and the maximum decreasing in BP. The time-weighted average which is measured by calculating the area under the threshold (AUT) divided by the total duration of colonoscopy. AUT = (depth of hypotension below a 20% decrease in systolic blood pressure or diastolic blood pressure from pre-procedure baseline or SBP of 90 mm Hg or DBP of 50 mm Hg× time in minutes spent of hypotension); (2) the incidence of bradycardia and hypoxemia, mask-assisted ventilation and body movement；(3) the discharge time , patients and endoscopists satisfaction score.
Interventions
DRUGDexmedetomidine group
In the dexmedetomidine group, dexmedetomidine was infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. If Ramsay sedation scale score reached 3, colonoscope was inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg was administrated as the rescue dose if body movement occurred during colonoscopy. In the propofol group, propofol was administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 until Ramsay score reached 3. During the whole process, propofol was given intermittently to maintain Ramsay score 3 to 4. If body movement happened, propofol 10mg was administrated every time.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged above 18 years 2. American Society of Anesthesiologists (ASA) physical status of 1-2 3. Patients scheduled for sedation colonoscopy
Exclusion criteria
1. Emergency patients 2. Body weight \< 40 kg or \>100 kg 3. Allergy to dexmedetomidine, propofol in this trail, a previous adverse reaction to dexmedetomidine or propofol 4. Pregnancy or lactation 5. Drug abusers 6. Participation in other clinical studies within the previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is the occurrence of hypotension | The time during gastroscopy, an average of 12 minutes | Hypotension is defined as a 20% decrease in systolic blood pressure or diastolic blood pressure from pre-procedure baseline, systolic blood pressure \< 90 mmHg, and/or diastolic blood pressure \< 50 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of bradycardia | The time during gastroscopy, an average of 12 minutes | Bradycardia is defined as HR \<50 beats/min |
| The incidence of hypoxemia | The time during gastroscopy, an average of 12 minutes | Hypoxemia is defined as a decrease of SpO2 to \<90% |
| The incidence of mask-assisted ventilation | The time during gastroscopy, an average of 12 minutes | Mask ventilation is performed if the hypoxemia happened |
| The duration and the maximum decreasing in BP | The time during gastroscopy, an average of 12 minutes | The time-weighted average which is measured by calculating the area under the threshold (AUT) divided by the total duration of colonoscopy. AUT = (depth of hypotension below a 20% decrease in systolic blood pressure or diastolic blood pressure from pre-procedure baseline or SBP of 90 mm Hg or DBP of 50 mm Hg× time in minutes spent of hypotension) |
| The discharge time | From the end of colonoscopy to discharge，an average of 30 minutes | The discharge time is calculated from the end of colonoscopy to discharge |
| Patients satisfaction score | When the patient is fully awake after colonoscopy，an average of 5 minutes | Using an 11-point Likert scale, with 0 indicating very dissatisfied and 10 indicating very satisfied |
| Endoscopists satisfaction score | At the end of colonoscopy | Using an 11-point Likert scale, with 0 indicating very dissatisfied and 10 indicating very satisfied |
| The incidence of body movement | The time during gastroscopy, an average of 12 minutes | Body movement is defined as the twisting of the patient's body due to the stimulation of the endoscopy, making it difficult to proceed with the procedure without additional propofol |
Countries
China
Outcome results
None listed