Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

Study Overview
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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.

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.

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

Conditions
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Midazolam, Sevoflurane

Intervention / Treatment
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* Drug: Midazolam
* Other: Saline


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group M<br>Patients receive midazolam IV at 0.04 mg/kg (group M). | Drug: Midazolam<br>* midazolam IV at 0.04 mg/kg<br>|
| Placebo Comparator: Group C<br>Patients receive an equal volume of saline IV (group C, control group). | Other: Saline<br>* an equal volume of saline IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sevoflurane consumption | The amount of sevoflurane consumed (ml) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end-tidal sevoflurane concentration (%) | end-tidal sevoflurane concentration (%) | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, Sevoflurane, Anxiety