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

NCT ID: NCT05242081

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

980 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Opioid Use, Unspecified S-ketamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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S-ketamine

Group Type EXPERIMENTAL

S-ketamine

Intervention Type DRUG

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

Sufentanil

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

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

Interventions

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S-ketamine

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

Intervention Type DRUG

Sufentanil

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ling Zhou

Role: CONTACT

+86 15895918786

Chun Yang

Role: CONTACT

+8618260062666

Facility Contacts

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Chun Yang

Role: primary

+86 18260062666

Other Identifiers

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2021-SR-480

Identifier Type: -

Identifier Source: org_study_id

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