Anesthesia for Loop Electrosurgical Excision Procedure (LEEP). (ESK，LEEP)

Efficacy and Safety of Propofol in Combination With Different Esketamine Doses for Anesthesia During Loop Electrosurgical Excision Procedure

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.

Study Overview

• Status: Completed
• Conditions: Propofol; Esketamine; Loop Electrosurgical Excision
• Intervention / Treatment: Drug: intravenous injection of propofol only; Drug: intravenous injection of propofol +esketamine

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group P; Intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol	Drug: intravenous injection of propofol only; Propofol was administered intravenously 2 mg/kg
Experimental: group PK1; Intravenous injection of 0.5 mg/kg esketamine followed by 1.5 mg/kg of propofol	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
Experimental: group PK2; Intravenous injection of 0.25 mg/kg esketamine followed by 1.5 mg/kg of propofol	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of additional propofol usage	The number of additional propofol was recorded	On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes
postoperative awakening time	The postoperative awakening time (MOAA/S score >4) was recorded	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
number of jaw thrust maneuver or face mask ventilation	The number of jaw thrust maneuver or face mask ventilation was recorded	On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes
incidences of postoperative vertigo, nausea, agitation and delirium	incidences of postoperative vertigo, nausea, agitation and delirium were recorded	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

Collaborators and Investigators

• Sponsor: Qian Wu
• Investigators: Principal Investigator: Gang Y Hao, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• Yan T, Zhang GH, Wang BN, Sun L, Zheng H. Effects of propofol/remifentanil-based total intravenous anesthesia versus sevoflurane-based inhalational anesthesia on the release of VEGF-C and TGF-beta and prognosis after breast cancer surgery: a prospective, randomized and controlled study. BMC Anesthesiol. 2018 Sep 22;18(1):131. doi: 10.1186/s12871-018-0588-3.
• Song N, Yang Y, Zheng Z, Shi WC, Tan AP, Shan XS, Liu H, Meng L, Peng K, Ji FH. Effect of Esketamine Added to Propofol Sedation on Desaturation and Hypotension in Bidirectional Endoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2347886. doi: 10.1001/jamanetworkopen.2023.47886.
• Oh C, Kim Y, Eom H, Youn S, Lee S, Ko YB, Yoo HJ, Chung W, Lim C, Hong B. Procedural Sedation Using a Propofol-Ketamine Combination (Ketofol) vs. Propofol Alone in the Loop Electrosurgical Excision Procedure (LEEP): A Randomized Controlled Trial. J Clin Med. 2019 Jun 28;8(7):943. doi: 10.3390/jcm8070943.
• Eberl S, Koers L, van Hooft J, de Jong E, Hermanides J, Hollmann MW, Preckel B. The effectiveness of a low-dose esketamine versus an alfentanil adjunct to propofol sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled multicentre trial. Eur J Anaesthesiol. 2020 May;37(5):394-401. doi: 10.1097/EJA.0000000000001134.
• Jonkman K, van Rijnsoever E, Olofsen E, Aarts L, Sarton E, van Velzen M, Niesters M, Dahan A. Esketamine counters opioid-induced respiratory depression. Br J Anaesth. 2018 May;120(5):1117-1127. doi: 10.1016/j.bja.2018.02.021. Epub 2018 Mar 26.
• Nie J, Chen W, Jia Y, Zhang Y, Wang H. Comparison of remifentanil and esketamine in combination with propofol for patient sedation during fiberoptic bronchoscopy. BMC Pulm Med. 2023 Jul 11;23(1):254. doi: 10.1186/s12890-023-02517-1.
• Trujillo KA, Heller CY. Ketamine sensitization: Influence of dose, environment, social isolation and treatment interval. Behav Brain Res. 2020 Jan 27;378:112271. doi: 10.1016/j.bbr.2019.112271. Epub 2019 Oct 5.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Propofol; Esketamine
• Other Study ID Numbers: 2022-71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No