Clinical trial NCT05371600: Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption
Official title: The Effect of Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Midazolam
Sevoflurane
Keywords: Midazolam
Sevoflurane
Anxiety
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Sevoflurane consumption
timeFrame: 1 hour
Secondary outcomes:
measure: end-tidal sevoflurane concentration (%)
timeFrame: 1 hour
Other outcomes:
measure: sevoflurane MAC
timeFrame: 1 hour
measure: inspiratory sevoflurane (%)
timeFrame: 1 hour
Locations:
city: Adana
country: Turkey
facility: Department of Anesthesiology, Cukurova University Faculty of Medicine
Study officials:
affiliation: Cukurova University
name: Ersel Gulec, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
citation: 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.
citation: 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.