Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

Phase 4

Completed

• Conditions: Sevoflurane; Midazolam
• Interventions: Other: Saline; Drug: Midazolam

• Registration Number: NCT05371600
• Lead Sponsor: Cukurova University

Brief Summary

This prospective, randomized, double-blind, placebo-controlled study is performed after obtaining written informed consent of patients who are scheduled for elective general surgery. After the admission to the preoperative unit 30 minutes before the surgery, The preoperative anxiety of patients is evaluated by The State-Trait Anxiety Inventory (STAI). Patients are randomly assigned to one of two groups in a 1:1 ratio by a computer-generated list. Patients receive midazolam IV at 0.04 mg/kg (group M) and an equal volume of saline IV (group C, control group). Anesthesia is induced with 2mg/kg of IV propofol. At a dose of 0.6 mg/kg, IV rocuronium bromide is given for neuromuscular blockade. Anesthesia is maintained at 2% sevoflurane. At the end of the surgery, anesthesia is terminated and the awake patients are extubated.

Detailed Description

An equal depth of anesthesia is achieved by evaluating an entropy value of 40-50 during the operation. Heart rate, blood pressure, the amount of sevoflurane consumed (ml), end-tidal sevoflurane concentration (%), sevoflurane MAC, inspiratory sevoflurane (%) are recorded at baseline and 15-minute intervals.

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-12
• Study Start: 2022-12-02
• Status Verified: 2024-04
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• American Society of Anesthesiologists physical status 1 and 2
• patients who are scheduled for elective surgery
• BMI <30

Exclusion Criteria

• history of psychiatric disease
• use of psychotropic medications
• neurological disorders
• cancer
• chronic pain
• cardiovascular, respiratory, and hepatic diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Saline	Patients receive an equal volume of saline IV (group C, control group).
Group M	Midazolam	Patients receive midazolam IV at 0.04 mg/kg (group M).

Primary Outcome Measures

Name	Time	Method
Sevoflurane consumption	1 hour	The amount of sevoflurane consumed (ml)

Secondary Outcome Measures

Name	Time	Method
end-tidal sevoflurane concentration (%)	1 hour	end-tidal sevoflurane concentration (%)

Trial Locations

Locations (1)

Department of Anesthesiology, Cukurova University Faculty of Medicine; 🇹🇷 Adana, Turkey