CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Midazolam +1 moredrug
Likely dose
Midazolam 0.04 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05371600
NCT05371600Phase 4Completed

The Effect of Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption: A Prospective Randomized Controlled Study

Cukurova University·interventional·Posted May 12, 2022·Updated May 1, 2024

In Brief

A Phase 4 clinical trial evaluating Midazolam and Saline for Midazolam and Sevoflurane. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMay 12, 2022
Enrollment StartDec 2, 2022
Primary CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.1 years ago

Interventions

Midazolamdrug

midazolam IV at 0.04 mg/kg

Salineother

an equal volume of saline IV