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

N/AUnknownNCT05242081

The First Affiliated Hospital with Nanjing Medical University980 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

980

Conditions

Opioid Use, Unspecified S-ketamine

Interventions

S-ketamineDRUG

S-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance

SufentanilDRUG

Sufentanil 0.2-0.3μg/kg for induction and remifentanil 0.05-0.15μg/kg/min for maintenance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 day of the surgery

Secondary Outcomes

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).

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From the date of the beginning of surgery until the date of the end of surgery, assessed up to 2 days

Time until awake

Time frame: From the end of anesthesia until awake, assessed up to 2 days

Central Contacts

Ling Zhou

CONTACT

+86 15895918786 lingzhou531@foxmail.com

Chun Yang

CONTACT

+8618260062666 chunyang@njmu.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.