Esketamine, Loop Electrosurgical Excision, Propofol
Conditions
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.
Interventions
DRUGintravenous injection of propofol only
Propofol was administered intravenously 2 mg/kg
DRUGintravenous 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
Sponsors
Qian Wu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure | 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 | Immediately upon entering the operating room and 5 minutes after injection of anesthetics | The venous carbon dioxide (PvCO2) was monitored using blood-gas analyzer |
| Respiratory Rate | 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 | Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics | The heart rate (HR) was monitored using 3-lead ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The number of additional propofol was recorded |
| 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 | The postoperative awakening time (MOAA/S score \>4) was recorded |
| 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 | The number of jaw thrust maneuver or face mask ventilation was recorded |
| 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 | incidences of postoperative vertigo, nausea, agitation and delirium were recorded |
Countries
China
Outcome results
None listed