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

Nanjing Medical University

Status: Enrolling

Conditions: S-ketamine; Opioid Use, Unspecified

Treatments: Drug: S-ketamine; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05242081

2021-SR-480

Details and patient eligibility

About

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.

Enrollment: 980 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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980 participants in 2 patient groups

S-ketamine

Experimental group

Treatment:

Drug: S-ketamine

Sufentanil

Active Comparator group

Treatment:

Drug: Sufentanil