Opioid Use, Unspecified, S-ketamine
Conditions
Brief summary
The purpose of this study was to observe the effects of opioid-free anesthesia with S-ketamine on postoperative analgesia and perioperative hemodynamics in short surgical operations, and to explore the effects of S-ketamine on postoperative awakening time and extubation time, nausea and vomiting, hypoxemia, and delirium.
Interventions
DRUGS-ketamine
S-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance
DRUGSufentanil
Sufentanil 0.2-0.3μg/kg for induction and remifentanil 0.05-0.15μg/kg/min for maintenance
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged from 18 years to 65 years 2. American society of anesthesiologists physical status classification I-II 3. Patients scheduled for elective laparoscopic cholecystectomy 4. Willing to sign informed consent
Exclusion criteria
1. Allergic to narcotic drugs; 2. Surgical history within the past 1 month; 3. patients with neurological diseases or mental disorders; 4. Unable to understand numerical rating Scale (NRS); 5. patients with untreated or poorly controlled hypertension (arterial hypertension, resting systolic/diastolic blood pressure over 180/100mmHg); 6. patients with untreated or undertreated hyperthyroidism; 7. Patients with unstable angina pectoris or myocardial infarction in the past 6 months; 8. When intraocular pressure is high (glaucoma) and penetrating ocular trauma, intraocular pressure cannot rise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU) | 1 day of the surgery | The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The area under the curve (AUC) of mean arterial pressure (MAP) within 10 minutes after induction is lower than the baseline mean arterial pressure (MAP 3 minutes before induction). | From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days | The area under the curve (AUC) of mean arterial pressure (MAP) within 10 minutes after induction is lower than the baseline mean arterial pressure (MAP 3 minutes before induction). |
| herat rate and blood pressure during the surgery every 5 minutes | From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days | — |
| Total dosage of anesthesia drug | From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days | — |
| Total dosage of vasoactive agents | From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days | — |
| The duration of surgery | From the date of the beginning of surgery until the date of the end of surgery, assessed up to 2 days | — |
| Time until awake | From the end of anesthesia until awake, assessed up to 2 days | — |
| Incidence of hypoxemia | 48 hours after the surgery | — |
| Incidence of postoperative nausea and vomiting | 48 hours after the surgery | — |
| Incidence of postoperative delirium | 48 hours after the surgery | — |
| Postoperative first analgesia demand | From the end of anesthesia until the date of first demand of analgesia drugs, assessed up to 1 week | The first time that the patient ask for analgesia |
| numerical rating scale (NRS) pain score | 24 hours and 48 hours after the surgery | — |
| Postoperative hospital stay | From the date of the surgery until the date being discharged from hospital, up to 1 month | — |
| Time to removal of tracheal intubation | From the end of anesthesia until the time of removal of tracheal intubation, assessed up to 2 days | — |
Countries
China
Contacts
Primary ContactLing Zhou
Backup ContactChun Yang
Outcome results
None listed