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CompletedNCT03325335Updated Oct 31, 2017

Assessing the Effectiveness of Midazolam Premedication

An interventional study of Midazolam premedication and Remifentanil infusion in Midazolam Premedication, Anxiety Preoperative and Premedication, sponsored by Pusan National University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Pusan National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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.

Read the detailed description

Background

  • Midazolam premedication is a routine practice in many hospitals, but its efficacy remains controversial. We evaluated the effectiveness of midazolam premedication with respect to anxiety and sedation levels, hemodynamic parameters, and analgesic profiles.

Methods

  • Subjects

    • This randomized, prospective, open-label study was approved by IRB. After written informed consent, a total of 128 female patients aged between 20 and 65 years, ASA physical status Ⅰ or Ⅱ, scheduled for elective thyroidectomy were enrolled. Exclusion criteria were: 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, and contraindication to midazolam premedication. Enrolled all subjects were randomly allocated to either midazolam premedication group (Group P, n=64) or control group (Group N, n=64). Patients of group P were premedicated with intramuscular glycopyrrolate 0.2mg and midazolam 0.05 mg/kg 30 minutes before surgery, while patients assigned to Group N were only received glycopyrrolate.

  • Anesthetic management

    • In the operating room, we did standard monitoring(ECG, pulse oximetry, noninvasive blood pressure, esophageal stethoscope temperature), train of four (TOF) and entropy and surgical pleth index(SPI). Target controlled infusion of propofol (4.0 μg/ml) and remifentanil (4 ng/ml) were used for induction of anesthesia based on the pharmacological models of Marsh and Minto, respectively. Intravenous rocuronium 1.0 mg/kg was administered for muscle relaxation. After intubation, propofol (3.0μg/ml) and remifentanil (2 ng/ml) were infused until incision time. 30 mg of ketorolac was administered 30 minutes before the end of the operation to control postoperative pain.

  • Assessment of response to midazolam

    • To evaluate the degree of anxiety, the Beck anxiety inventory was conducted at the preoperative day before surgery and immediately after arrival at the operating room. For analgesic profile assessment, SPI monitoring was performed in the operating room and NRS (numeric rating scale) measured in the recovery room and the general ward until the transition to oral analgesics. Also, additional medications for pain control were reviewed. Noninvasive blood pressure, heart rate, and entropy value were recorded at each measuring points in order to evaluate the hemodynamic stability and sedation level during anesthesia induction. Measuring points were initial time, prior to intubation, intubation, prior to incision and incision time. The time taken to induce anesthesia was also recorded.

  • Sample size and statistical analysis

    • In this study, sample size was determined based on Cohen's study. According to this analysis, when comparing the mean of two groups with α (significance criterion) = 0.05, β (probability of occurring type II error) = 0.2 and medium effect size (Cohen's d = 0.5), 64 subjects were needed per group.
    • After a normality test, continuous variables were analyzed with the use of an independent t-test, paired t-test, and repeated-measures ANOVA. Differences between categorical variables were calculated with the use of the chi-square test.
02

Conditions studied

  • Midazolam Premedication
  • Anxiety Preoperative
  • Premedication

Keywords

  • midazolam premedication
03

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (actual)

Study arms

  • Active comparator
    Midazolam premedication group (Group P)

    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

  • Other
    Control group (Group N)

    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

  • DrugMidazolam premedication

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

    Also known as: Intramuscular midazolam

  • DrugRemifentanil infusion

    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

  • DrugPropofol infusion

    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

05

What researchers measure

Primary outcomes

  1. 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.

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

  2. Change in sedation level

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

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

  3. Change in noninvasive blood pressure (hemodynamic parameters 1)

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

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

  4. 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

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

  5. Numeric rating scale (Analgesic profile 2)

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

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

  6. Analgesic requirement (Analgesic profile 3)

    Reviewing additional medications for pain control

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

  7. Change in heart rate (hemodynamic parameters 2)

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

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

Secondary outcomes

  1. Procedure time of intubation

    Total time taken for intubation was recorded

    Time frame: From the beginning of anesthesia to the completion of intubation

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

    Measuring SPI, noninvasive blood pressure, heart rate, and entropy values (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA)

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

06

Study locations

1 site
  • Pusan national university hospital
    Busan, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03325335
Lead sponsor
Pusan National University Hospital
Responsible party
Hyeon-Jeong Lee (Associate professor, Pusan National University Hospital) — Principal investigator
First posted
Oct 30, 2017
Start date
Jul 19, 2016
Primary completion
Aug 14, 2017
Completion
Aug 15, 2017
Last update
Oct 31, 2017

Study contacts

Hyeon-Jeong Lee, PhD
principal investigator · Pusan National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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