Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).

NCT06574945 | Completed Phase 4

• 1 other identifier: 2022-71
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Esketamine; Loop Electrosurgical Excision; Propofol

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

group P

PLACEBO COMPARATOR

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

Drug: intravenous injection of propofol only

group PK1

EXPERIMENTAL

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

Drug: intravenous injection of propofol +esketamine

group PK2

EXPERIMENTAL

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

Drug: intravenous injection of propofol +esketamine

Interventions

intravenous injection of propofol only DRUG

Propofol was administered intravenously 2 mg/kg

group P

intravenous injection of propofol +esketamine 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 PK1; group PK2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: cervical lesions
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qian Wu: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Related Publications (7)

• 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.

  PMID: 30243294 BACKGROUND

• 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.

  PMID: 38117498 BACKGROUND

• 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.

  PMID: 31261820 BACKGROUND

• 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.

  PMID: 31860599 BACKGROUND

• 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.

  PMID: 29661389 BACKGROUND

• 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.

  PMID: 37430293 BACKGROUND

• 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.

  PMID: 31593791 BACKGROUND

Study Officials

• Gang Y Hao

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 28, 2024
• Study Start: January 7, 2022
• Primary Completion: January 7, 2022
• Study Completion: October 28, 2022
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)