NCT05242081UnknownNot Applicable
Efficacy and Safety of Opioid-free Anesthesia With Propofol Combined With S-ketamine in Laparoscopic Cholecystectomy: a Multicenter, Randomized, Controlled, Non-inferiority Clinical Study (SKOF - LC)
The First Affiliated Hospital with Nanjing Medical University1 site in 1 country980 target enrollmentStarted: July 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 980
- Locations
- 1
- Primary Endpoint
- The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged from 18 years to 65 years
- •American society of anesthesiologists physical status classification I-II
- •Patients scheduled for elective laparoscopic cholecystectomy
- •Willing to sign informed consent
Exclusion Criteria
- •Allergic to narcotic drugs;
- •Surgical history within the past 1 month;
- •patients with neurological diseases or mental disorders;
- •Unable to understand numerical rating Scale (NRS);
- •patients with untreated or poorly controlled hypertension (arterial hypertension, resting systolic/diastolic blood pressure over 180/100mmHg);
- •patients with untreated or undertreated hyperthyroidism;
- •Patients with unstable angina pectoris or myocardial infarction in the past 6 months;
- •When intraocular pressure is high (glaucoma) and penetrating ocular trauma, intraocular pressure cannot rise.
Arms & Interventions
S-ketamine
Experimental
Intervention: S-ketamine (Drug)
Sufentanil
Active Comparator
Intervention: Sufentanil (Drug)
Outcomes
Primary Outcomes
The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU)
Time Frame: 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 Outcomes
- Incidence of hypoxemia(48 hours after the surgery)
- 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 to removal of tracheal intubation(From the end of anesthesia until the time of removal of tracheal intubation, assessed up to 2 days)
- Incidence of postoperative nausea and vomiting(48 hours after the surgery)
- Incidence of postoperative delirium(48 hours after the surgery)
- numerical rating scale (NRS) pain score(24 hours and 48 hours after the surgery)
- 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)
- 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)
- Time until awake(From the end of anesthesia until awake, 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)
- Postoperative first analgesia demand(From the end of anesthesia until the date of first demand of analgesia drugs, assessed up to 1 week)
- Postoperative hospital stay(From the date of the surgery until the date being discharged from hospital, up to 1 month)
Investigators
Study Sites (1)
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