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Completed

NCT Number: NCT06574945

Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).

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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Key information

Conditions

Esketamine Loop Electrosurgical Excision Propofol

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous injection of propofol only

Drug

Propofol was administered intravenously 2 mg/kg

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

Primary outcomes

  1. Respiratory Rate

    Time frame: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics

    The respiratory rate (RR) was monitored from 3-lead ECG

  2. Heart Rate

    Time frame: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics

    The heart rate (HR) was monitored using 3-lead ECG

  3. Mean Arterial Pressure

    Time frame: 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

  4. Venous Carbon Dioxide

    Time frame: 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 outcomes

  1. number of additional propofol usage

    Time frame: 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

  2. postoperative awakening time

    Time frame: 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

  3. number of jaw thrust maneuver or face mask ventilation

    Time frame: 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

  4. incidences of postoperative vertigo, nausea, agitation and delirium

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Qian Wu

Other

Registry information

Official study title

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

Acronym: ESK，LEEP

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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