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NCT Number: NCT05371600

Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

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.

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Key information

Conditions

Midazolam Anxiety Disorders Mental Disorders Sevoflurane

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Cukurova University Faculty of Medicine

Adana, 01130, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam

Drug

midazolam IV at 0.04 mg/kg

Saline

Other

an equal volume of saline IV

Primary outcomes

  1. Sevoflurane consumption

    Time frame: 1 hour

    The amount of sevoflurane consumed (ml)

Secondary outcomes

  1. end-tidal sevoflurane concentration (%)

    Time frame: 1 hour

    end-tidal sevoflurane concentration (%)

Other outcomes

  1. sevoflurane MAC

    Time frame: 1 hour

    sevoflurane MAC

  2. inspiratory sevoflurane (%)

    Time frame: 1 hour

    inspiratory sevoflurane (%)

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 12, 2022
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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