Clinical trial NCT06574945: Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).
Official title: Efficacy and Safety of Propofol in Combination With Different Esketamine Doses for Anesthesia During Loop Electrosurgical Excision Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esketamine
Loop Electrosurgical Excision
Propofol
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Rate
timeFrame: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics
measure: Heart Rate
timeFrame: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics
measure: Mean Arterial Pressure
timeFrame: Immediately upon entering the operating room, 1 and 5 minutes after injection of anesthetics
measure: Venous Carbon Dioxide
timeFrame: Immediately upon entering the operating room and 5 minutes after injection of anesthetics
Secondary outcomes:
measure: number of additional propofol usage
timeFrame: On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes
measure: postoperative awakening time
timeFrame: 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
measure: number of jaw thrust maneuver or face mask ventilation
timeFrame: On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes
measure: incidences of postoperative vertigo, nausea, agitation and delirium
timeFrame: 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
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Gang Y Hao
role: PRINCIPAL_INVESTIGATOR
References:
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