Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-02

Study Completion Date

2024-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Midazolam Sevoflurane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group M

Patients receive midazolam IV at 0.04 mg/kg (group M).

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

midazolam IV at 0.04 mg/kg

Group C

Patients receive an equal volume of saline IV (group C, control group).

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

an equal volume of saline IV

Interventions

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Midazolam

midazolam IV at 0.04 mg/kg

Intervention Type DRUG

Saline

an equal volume of saline IV

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No