Study on Opioid-free Anesthesia Protocol With S-ketamine and Propofol

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Opioid Use, Unspecified, S-ketamine

Intervention / Treatment
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* Drug: S-ketamine
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-ketamine<br> | Drug: S-ketamine<br>* S-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance<br>|
| Active Comparator: Sufentanil<br> | Drug: Sufentanil<br>* Sufentanil 0.2-0.3μg/kg for induction and remifentanil 0.05-0.15μg/kg/min for maintenance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 
| 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 | 
| 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 | 
| Incidence of hypoxemia |  | 48 hours after the surgery | 
| Postoperative first analgesia demand | The first time that the patient ask for analgesia | From the end of anesthesia until the date of first demand of analgesia drugs, assessed up to 1 week | 
| 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 |