NCT05371600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 2, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

May 9, 2022

Last Update Submit

April 30, 2024

Conditions

MidazolamSevoflurane

Keywords

MidazolamSevofluraneAnxiety

Outcome Measures

Primary Outcomes (1)

  • Sevoflurane consumption

    The amount of sevoflurane consumed (ml)

    1 hour

Secondary Outcomes (1)

  • end-tidal sevoflurane concentration (%)

    1 hour

Other Outcomes (2)

  • sevoflurane MAC

    1 hour

  • inspiratory sevoflurane (%)

    1 hour

Study Arms (2)

Group M

ACTIVE COMPARATOR

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

Drug: Midazolam

Group C

PLACEBO COMPARATOR

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

Other: Saline

Interventions

MidazolamDRUG

midazolam IV at 0.04 mg/kg

Group M
SalineOTHER

an equal volume of saline IV

Group C

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists physical status 1 and 2
  • patients who are scheduled for elective surgery
  • BMI \<30

You may not qualify if:

  • history of psychiatric disease
  • use of psychotropic medications
  • neurological disorders
  • cancer
  • chronic pain
  • cardiovascular, respiratory, and hepatic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Cukurova University Faculty of Medicine

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 22084330BACKGROUND

  • Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.

    PMID: 10589606BACKGROUND

  • 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.

    PMID: 7114548BACKGROUND

  • 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.

    PMID: 19672167BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

MidazolamSodium Chloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ersel Gulec, MD

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 12, 2022

Study Start

December 2, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)