Last reviewed · How we verify

NCT05371600

Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

Completed Phase 4 Last updated 1 May 2024
What this trial tests

Phase 4 trial testing Midazolam in Midazolam in 80 participants. Completed in 30 April 2024.

Timeline
2 December 2022
Primary endpoint
30 April 2024
30 April 2024

Quick facts

Lead sponsorCukurova University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment80
Start date2 December 2022
Primary completion30 April 2024
Estimated completion30 April 2024
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Cukurova University

Who can join

Adults 18 to 60, any sex, with Midazolam or Sevoflurane. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Midazolam

Trials testing the same drug.

Other recruiting trials for Midazolam

Currently open trials in the same condition.

Other Cukurova University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05371600.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing