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

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 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 Overview

• Status: Recruiting
• Conditions: Opioid Use, Unspecified; S-ketamine
• Intervention / Treatment: Drug: S-ketamine; Drug: Sufentanil

• Study Type: Interventional
• Enrollment (Anticipated): 980
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ling Zhou; Phone Number: +86 15895918786; Email: lingzhou531@foxmail.com
• Study Contact Backup: Name: Chun Yang; Phone Number: +8618260062666; Email: chunyang@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Chun Yang; Phone Number: +86 18260062666; Email: chunyang@njmu.edu.cn
      • Principal Investigator: Chun Yang, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: S-ketamine	Drug: S-ketamine; S-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance
ACTIVE_COMPARATOR: Sufentanil	Drug: Sufentanil; Sufentanil 0.2-0.3μg/kg for induction and remifentanil 0.05-0.15μg/kg/min for maintenance

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (ACTUAL): February 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Adjuvants, Anesthesia; Ketamine; Esketamine; Sufentanil
• Other Study ID Numbers: 2021-SR-480

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No