Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 (%), expiratory sevoflurane (%) are recorded at baseline and 15-minute intervals.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group M Patients receive midazolam IV at 0.04 mg/kg (group M). |
Drug: Midazolam
midazolam IV at 0.04 mg/kg
|
| Placebo Comparator: Group C Patients receive an equal volume of saline IV (group C, control group). |
Other: Saline
an equal volume of saline IV
|
Outcome Measures
Primary Outcome Measures
- Sevoflurane consumption [1 hour]
The amount of sevoflurane consumed (ml)
Secondary Outcome Measures
- end-tidal sevoflurane concentration (%) [1 hour]
end-tidal sevoflurane concentration (%)
Other Outcome Measures
- sevoflurane MAC [1 hour]
sevoflurane MAC
- inspiratory sevoflurane (%) [1 hour]
inspiratory sevoflurane (%)
- expiratory sevoflurane (%) [1 hour]
expiratory sevoflurane (%)
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesiology, Cukurova University Faculty of Medicine | Adana | Turkey | 01130 |
Sponsors and Collaborators
- Cukurova University
Investigators
- Principal Investigator: Ersel Gulec, MD, Cukurova University
Study Documents (Full-Text)
None provided.More Information
Publications
- Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a. Review.
- Kil HK, Kim WO, Chung WY, Kim GH, Seo H, Hong JY. Preoperative anxiety and pain sensitivity are independent predictors of propofol and sevoflurane requirements in general anaesthesia. Br J Anaesth. 2012 Jan;108(1):119-25. doi: 10.1093/bja/aer305. Epub 2011 Nov 13.
- Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51.
- Melvin MA, Johnson BH, Quasha AL, Eger EI 3rd. Induction of anesthesia with midazolam decreases halothane MAC in humans. Anesthesiology. 1982 Sep;57(3):238-41.
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