Efficacy and Safety of Propofol in Combination With Different Esketamine Doses for Anesthesia During Loop Electrosurgical Excision Procedure
Overview
- Phase
- Phase 4
- Intervention
- intravenous injection of propofol +esketamine
- Conditions
- Esketamine
- Sponsor
- Qian Wu
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Respiratory Rate
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Qian Wu
Principal Investigator
First Affiliated Hospital of Chongqing Medical University
Eligibility Criteria
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
Arms & Interventions
group PK1
Intravenous injection of 0.5 mg/kg esketamine followed by 1.5 mg/kg of propofol
Intervention: intravenous injection of propofol +esketamine
group P
Intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol
Intervention: intravenous injection of propofol only
group PK2
Intravenous injection of 0.25 mg/kg esketamine followed by 1.5 mg/kg of propofol
Intervention: intravenous injection of propofol +esketamine
Outcomes
Primary Outcomes
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
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
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
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
- 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)
- 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)