Skip to content

Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05371600
Enrollment
80
Registered
2022-05-12
Start date
2022-12-02
Completion date
2024-04-30
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Midazolam, Sevoflurane

Keywords

Midazolam, Sevoflurane, Anxiety

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.

Interventions

DRUGMidazolam

midazolam IV at 0.04 mg/kg

OTHERSaline

an equal volume of saline IV

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sevoflurane consumption1 hourThe amount of sevoflurane consumed (ml)

Secondary

MeasureTime frameDescription
end-tidal sevoflurane concentration (%)1 hourend-tidal sevoflurane concentration (%)

Other

MeasureTime frameDescription
sevoflurane MAC1 hoursevoflurane MAC
inspiratory sevoflurane (%)1 hourinspiratory sevoflurane (%)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026