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

Not Applicable

• Conditions: S-ketamine; Opioid Use, Unspecified
• Interventions: Drug: S-ketamine; Drug: Sufentanil

• Registration Number: NCT05242081
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-16
• Status Verified: 2022-07
• Study Start: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 980

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-ketamine	S-ketamine	-
Sufentanil	Sufentanil	-

Primary Outcome Measures

Name	Time	Method
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	The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU)

Secondary Outcome Measures

Name	Time	Method
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	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).
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	The first time that the patient ask for analgesia
Postoperative hospital stay	From the date of the surgery until the date being discharged from hospital, up to 1 month

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China