Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).

Phase 4

Completed

• Conditions: Esketamine; Loop Electrosurgical Excision; Propofol
• Interventions: Drug: intravenous injection of propofol only; Drug: intravenous injection of propofol +esketamine

• Registration Number: NCT06574945
• Lead Sponsor: Qian Wu

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-07
• Primary Completion: 2022-01-07
• Study Completion: 2022-10-28
• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group P	intravenous injection of propofol only	Intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol
group PK1	intravenous injection of propofol +esketamine	Intravenous injection of 0.5 mg/kg esketamine followed by 1.5 mg/kg of propofol
group PK2	intravenous injection of propofol +esketamine	Intravenous injection of 0.25 mg/kg esketamine followed by 1.5 mg/kg of propofol

Primary Outcome Measures

Name	Time	Method
Respiratory Rate	Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics	The respiratory rate (RR) was monitored from 3-lead ECG
Heart Rate	Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics	The heart rate (HR) was monitored using 3-lead ECG
Mean Arterial Pressure	Immediately upon entering the operating room, 1 and 5 minutes after injection of anesthetics	The mean arterial pressure (MAP) was monitored using Noninvasive blood pressure monitor
Venous Carbon Dioxide	Immediately upon entering the operating room and 5 minutes after injection of anesthetics	The venous carbon dioxide (PvCO2) was monitored using blood-gas analyzer

Secondary Outcome Measures

Name	Time	Method
number of jaw thrust maneuver or face mask ventilation	On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes	The number of jaw thrust maneuver or face mask ventilation was recorded
incidences of postoperative vertigo, nausea, agitation and delirium	On the day of surgery,from the moment the patient wakes up (when MOAA score >4) to the moment the patient leaving the recovery room,up to 30minutes	incidences of postoperative vertigo, nausea, agitation and delirium were recorded
number of additional propofol usage	On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes	The number of additional propofol was recorded
postoperative awakening time	On the day of surgery, from the instant completion of surgery to the moment the patient wakes up (when MOAA score >4),up to 10 minutes	The postoperative awakening time (MOAA/S score \>4) was recorded

Trial Locations

Locations (1)

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