Anesthesia for Loop Electrosurgical Excision Procedure (LEEP). (ESK，LEEP)

Qian Wu

Status and phase: Completed; Phase 4

Conditions: Esketamine; Propofol; Loop Electrosurgical Excision

Treatments: Drug: intravenous injection of propofol +esketamine; Drug: intravenous injection of propofol only

Study type: Interventional

Funder types: Other

Identifiers

NCT06574945

2022-71

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

group P

Placebo Comparator group

Description:

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

Treatment:

Drug: intravenous injection of propofol only

group PK1

Experimental group

Description:

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

Treatment:

Drug: intravenous injection of propofol +esketamine

group PK2

Experimental group

Description:

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

Treatment:

Drug: intravenous injection of propofol +esketamine