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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group M | Active Comparator | Patients receive midazolam IV at 0.04 mg/kg (group M). |
|
| Group C | Placebo Comparator | Patients receive an equal volume of saline IV (group C, control group). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | midazolam IV at 0.04 mg/kg |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Sevoflurane consumption | The amount of sevoflurane consumed (ml) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| end-tidal sevoflurane concentration (%) | end-tidal sevoflurane concentration (%) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| sevoflurane MAC | sevoflurane MAC | 1 hour |
| inspiratory sevoflurane (%) | inspiratory sevoflurane (%) | 1 hour |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ersel Gulec, MD | Cukurova University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Cukurova University Faculty of Medicine | Adana | 01130 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22084330 | Background | 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. | |
| 10589606 | Background | Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Other |
an equal volume of saline IV |
|
| 7114548 | Background | 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. doi: 10.1097/00000542-198209000-00018. No abstract available. |
| 19672167 | Background | 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. |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |