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

Opioid Use, Unspecified Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242081
• Other study ID #: 2021-SR-480
• Status: Recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: June 2023

Study information

• Verified date: July 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Ling Zhou
• Phone: +86 15895918786
• Email: lingzhou531[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 980
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use, Unspecified
• S-ketamine

Intervention

Drug:
• S-ketamine
S-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance
• Sufentanil
Sufentanil 0.2-0.3µg/kg for induction and remifentanil 0.05-0.15µg/kg/min for maintenance

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time until awake		From the end of anesthesia until awake, assessed up to 2 days
Secondary	Time to removal of tracheal intubation		From the end of anesthesia until the time of removal of tracheal intubation, assessed up to 2 days
Secondary	Incidence of postoperative nausea and vomiting		48 hours after the surgery
Secondary	Incidence of postoperative delirium		48 hours after the surgery
Secondary	Incidence of hypoxemia		48 hours after the surgery
Secondary	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
Secondary	numerical rating scale (NRS) pain score		24 hours and 48 hours after the surgery
Secondary	Postoperative hospital stay		From the date of the surgery until the date being discharged from hospital, up to 1 month