Assessing the Effectiveness of Midazolam Premedication

NCT03325335 | Completed

• 1 other identifier: 1607-003-057
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-anesthetic dosing of midazolam is commonly used in many hospitals for the induction of anesthesia, but the effect is still controversial. The purpose of this study was to evaluate the effectiveness of midazolam premedication in four aspects: anxiety reduction, pain relief, sedation and hemodynamic stability.

Conditions

Midazolam Premedication; Anxiety Preoperative; Premedication

Keywords

midazolam premedication

Outcome Measures

Primary Outcomes (7)

• Change in degree of anxiety

  Patients completed the Beck anxiety inventory (BAI) on two separate occasions, the anesthesiologist's visit on the day before surgery and pre-induction time after randomization. The BAI was a self-report questionnaire consisting of 21 questions.

  the anesthesiologist's visit on the day before surgery and pre-induction time after randomization

• Change in sedation level

  Measuring the entropy value (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA).

  At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision

• Change in noninvasive blood pressure (hemodynamic parameters 1)

  Measuring noninvasive blood pressure (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA)

  At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision

• Change in SPI value (Analgesic profile 1)

  Measuring SPI (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA), which was calculated from the pulse oximetry wave

  At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision

• Numeric rating scale (Analgesic profile 2)

  Reviewing numeric rating scale (NRS) : 0 (No pain) \~ 10 (Worst possible pain)

  Postoperative period (until transition to oral analgesics, up to 12 hours)

• Analgesic requirement (Analgesic profile 3)

  Reviewing additional medications for pain control

  Postoperative period (until transition to oral analgesics, up to 12 hours)

• Change in heart rate (hemodynamic parameters 2)

  Measuring heart rate (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA)

  At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision

Secondary Outcomes (2)

• Procedure time of intubation

  From the beginning of anesthesia to the completion of intubation

• Correlation analysis between the SPI values and other parameters (heart rate, blood pressure, and entropy values)

  At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision

Study Arms (2)

Midazolam premedication group (Group P)

ACTIVE COMPARATOR

Patients of group P were premedicated with intramuscular midazolam 0.05 mg/kg 30 minutes before surgery.

Drug: Midazolam premedication; Drug: Remifentanil infusion; Drug: Propofol infusion

Control group (Group N)

OTHER

Patients of group N were not premedicated with midazolam (Do not use placebo). \[Treatment of Glycopyrrolate (0.2 mg, IM) 30 minutes prior to surgery is not intervention because it is a routine practice of this center. (-\> removed from interventions)\]

Drug: Remifentanil infusion; Drug: Propofol infusion

Interventions

Midazolam premedication DRUG

Patients in Group P received midazolam (0.05 mg/kg, intramuscular injection) 30 minutes before induction of general anesthesia.

Also known as: Intramuscular midazolam

Midazolam premedication group (Group P)

Remifentanil infusion DRUG

Target controlled infusion of remifentanil (4ng/ml) was used for induction of anesthesia based on the pharmacological models of Minto. After intubation, remifentanil (2 ng/ml) was infused until incision time. (Both groups)

Also known as: Target-controlled infusion (TCI) of remifentanil

Control group (Group N); Midazolam premedication group (Group P)

Propofol infusion DRUG

Target controlled infusion of propofol (4.0 μg/ml) was used for induction of anesthesia based on the pharmacological models of Marsh. After intubation, propofol (3.0μg/ml) was infused until incision time. (Both groups)

Also known as: Target-controlled infusion (TCI) of propofol

Control group (Group N); Midazolam premedication group (Group P)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status classification I or II
• Scheduled for elective thyroidectomy under general anesthesia

You may not qualify if:

• Central nervous system disorders
• Major cardiovascular disease
• Chronic pain disorders
• Peripheral neuropathy
• Diabetes mellitus neuropathy
• Nephropathy
• Hepatopathy
• Taking any medication affecting the central nervous system or heart rate
• Alcohol or drug abuse
• Pregnancy
• Contraindication to midazolam premedication

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan national university hospital

Busan, South Korea

Location

MeSH Terms

Interventions

Transcobalamins; Remifentanil; Propofol

Intervention Hierarchy (Ancestors)

Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Carrier Proteins; Globulins; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hyeon-Jeong Lee, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: October 30, 2017
• Study Start: July 19, 2016
• Primary Completion: August 14, 2017
• Study Completion: August 15, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)