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)
1 other identifier
interventional
980
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJuly 20, 2022
July 1, 2022
5 months
January 13, 2022
July 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
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
- +8 more secondary outcomes
Study Arms (2)
S-ketamine
EXPERIMENTALSufentanil
ACTIVE COMPARATORInterventions
Sufentanil 0.2-0.3μg/kg for induction and remifentanil 0.05-0.15μg/kg/min for maintenance
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2022
First Posted
February 16, 2022
Study Start
July 1, 2022
Primary Completion
December 1, 2022
Study Completion
June 1, 2023
Last Updated
July 20, 2022
Record last verified: 2022-07