Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2022-10-28

Brief Summary

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The goal of this prospective, randomized controlled study study is to investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP).Ninety female patients undergoing LEEP were randomly allocated to three groups.It aims to answer :1.The effect of esketamine combined with propofol in respiration, circulation, etc,during LEEP. 2.The appropriate dosage of esketamine when combined with propofol in LEEP anesthesia.

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Detailed Description

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To investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP). Ninety female patients undergoing LEEP were randomly allocated to three groups: group P (2 mg/kg propofol + saline), group propofol + esketamine(PK)1 (1.5 mg/kg propofol + 0.5 mg/kg ESK), and group PK2 (1.5 mg/kg propofol + 0.25 mg/kg ESK). Parameters including mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SPO2), and venous carbon dioxide (PvCO2) were recorded. Additionally, the need for supplemental propofol, jaw thrust maneuver or ventilation, postoperative awakening time, and adverse reactions were assessed.

Conditions

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Esketamine Loop Electrosurgical Excision Propofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were categorized into three groups: propofol (2 mg/kg) + normal saline (group P), propofol (1.5 mg/kg) + ESK (0.5 mg/kg) (group PK1), and propofol (1.5 mg/kg) + ESK (0.25 mg/kg) (group PK2). In group P, patients received an intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol. Group PK1 received an intravenous injection of 0.5 mg/kg ESK followed by 1.5 mg/kg of propofol. Similarly, group PK2 received an intravenous injection of 0.25 mg/kg ESK followed by 1.5 mg/kg of propofol.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group P

Intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol

Group Type PLACEBO_COMPARATOR

intravenous injection of propofol only

Intervention Type DRUG

Propofol was administered intravenously 2 mg/kg

group PK1

Intravenous injection of 0.5 mg/kg esketamine followed by 1.5 mg/kg of propofol

Group Type EXPERIMENTAL

intravenous injection of propofol +esketamine

Intervention Type DRUG

intravenous injection of 0.5 mg/kg ESK followed by 1.5 mg/kg of propofol or intravenous injection of 0.25 mg/kg ESK followed by 1.5 mg/kg of propofol

group PK2

Intravenous injection of 0.25 mg/kg esketamine followed by 1.5 mg/kg of propofol

Group Type EXPERIMENTAL

intravenous injection of propofol +esketamine

Intervention Type DRUG

intravenous injection of 0.5 mg/kg ESK followed by 1.5 mg/kg of propofol or intravenous injection of 0.25 mg/kg ESK followed by 1.5 mg/kg of propofol

Interventions

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intravenous injection of propofol only

Propofol was administered intravenously 2 mg/kg

Intervention Type DRUG

intravenous injection of propofol +esketamine

intravenous injection of 0.5 mg/kg ESK followed by 1.5 mg/kg of propofol or intravenous injection of 0.25 mg/kg ESK followed by 1.5 mg/kg of propofol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who will undergo Loop Electrosurgical Excision Procedure
* The age of the patients ranged from 20 to 60 years old
* Paients had a BMI of 18-30 kg/m2
* ASA physical status grade of I or II

Exclusion Criteria

* Patients who refused to participate
* History of hypertension, hyperthyroidism, or neurological or mental disorder
* Currently taking or has taken opioids and non-steroidal anti-inflammatory drugs within 48 h before surgery
* Participated in other drug clinical trials within 4 weeks
* Allergy to esketamine or propofol
* History of opioid or esketamine addiction

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes