Midazolam PremedicationNCT03325335
Assessing the Effectiveness of Midazolam Premedication
A study testing Midazolam premedication, Remifentanil infusion and Propofol infusion in people with Midazolam Premedication and Anxiety Preoperative, run by Pusan National University Hospital at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Midazolam Premedication, Anxiety Preoperative, Premedication
- What is being tested?
- Midazolam premedication, Remifentanil infusion and Propofol infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2016to 15 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status classification I or II
- Scheduled for elective thyroidectomy under general anesthesia
Who cannot join
- Central nervous system disorders
- Major cardiovascular disease
- Chronic pain disorders
- Peripheral neuropathy
- Diabetes mellitus neuropathy
- Nephropathy
Show all 11Show fewer
- Hepatopathy
- Taking any medication affecting the central nervous system or heart rate
- Alcohol or drug abuse
- Pregnancy
- Contraindication to midazolam premedication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Assessing the Effectiveness of Midazolam Premedication as an Anxiolytic, Analgesic, Sedative, and Hemodynamic Stabilizer
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.
- Conditions
- Midazolam Premedication, Anxiety Preoperative, Premedication
- Being tested
- Midazolam premedication, Remifentanil infusion, Propofol infusion
- Keywords
- midazolam premedication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam premedicationDrug
Also called Intramuscular midazolam
Patients in Group P received midazolam (0.05 mg/kg, intramuscular injection) 30 minutes before induction of general anesthesia.
Remifentanil infusionDrug
Also called Target-controlled infusion (TCI) of remifentanil
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)
Propofol infusionDrug
Also called Target-controlled infusion (TCI) of propofol
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)
| Study group | Role | What they receive |
|---|---|---|
| Midazolam premedication group (Group P) | Active comparator | Patients of group P were premedicated with intramuscular midazolam 0.05 mg/kg 30 minutes before surgery. Receives: 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)] Receives: Drug: Remifentanil infusion; Drug: Propofol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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)
Measured: Postoperative period (until transition to oral analgesics, up to 12 hours)
Analgesic requirement (Analgesic profile 3)
Reviewing additional medications for pain control
Measured: 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)
Measured: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Secondary outcomes (2)
Procedure time of intubation
Total time taken for intubation was recorded
Measured: 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)
Measuring SPI, noninvasive blood pressure, heart rate, and entropy values (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA)
Measured: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start19 Jul 2016
- Primary completion14 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midazolam PremedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Jeong Lee, Pusan National University Hospital
- Investigators
- Hyeon-Jeong Lee, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325335
- Sponsor's protocol ID
- 1607-003-057
- Status last verified
- Oct 2017
- First submitted
- 22 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Assessing the Effectiveness of Midazolam Premedication as an Anxiolytic, Analgesic, Sedative, and Hemodynamic Stabilizer
- ClinicalTrials.gov ID
- NCT03325335
- Acronym / sponsor ID
- 1607-003-057
- Conditions
- Midazolam Premedication, Anxiety Preoperative, Premedication
- Keywords
- midazolam premedication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam premedication group (Group P) | Active comparator | Drug: Midazolam premedication, Drug: Remifentanil infusion, Drug: Propofol infusionPatients of group P were premedicated with intramuscular midazolam 0.05 mg/kg 30 minutes before surgery. |
| Control group (Group N) | Other | Drug: Remifentanil infusion, Drug: Propofol infusionPatients 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)] |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status classification I or II
- Scheduled for elective thyroidectomy under general anesthesia
Key exclusion criteria (11 listed)
- Central nervous system disorders
- Major cardiovascular disease
- Chronic pain disorders
- Peripheral neuropathy
- Diabetes mellitus neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam premedicationAlso: Intramuscular midazolamPatients in Group P received midazolam (0.05 mg/kg, intramuscular injection) 30 minutes before induction of general anesthesia. | Drug | Midazolam premedication group (Group P) |
| Remifentanil infusionAlso: Target-controlled infusion (TCI) of remifentanilTarget 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) | Drug | Control group (Group N), Midazolam premedication group (Group P) |
| Propofol infusionAlso: Target-controlled infusion (TCI) of propofolTarget 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) | Drug | Control group (Group N), Midazolam premedication group (Group P) |
Primary outcome
Change in degree of anxiety
Time frame: the anesthesiologist's visit on the day before surgery and pre-induction time after randomization
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.
Change in sedation level
Time frame: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Measuring the entropy value (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA).
Change in noninvasive blood pressure (hemodynamic parameters 1)
Time frame: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Measuring noninvasive blood pressure (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA)
Change in SPI value (Analgesic profile 1)
Time frame: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Measuring SPI (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA), which was calculated from the pulse oximetry wave
Numeric rating scale (Analgesic profile 2)
Time frame: Postoperative period (until transition to oral analgesics, up to 12 hours)
Reviewing numeric rating scale (NRS) : 0 (No pain) ~ 10 (Worst possible pain)
Analgesic requirement (Analgesic profile 3)
Time frame: Postoperative period (until transition to oral analgesics, up to 12 hours)
Reviewing additional medications for pain control
Change in heart rate (hemodynamic parameters 2)
Time frame: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Measuring heart rate (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA)
2 secondary outcomes
Procedure time of intubation
Time frame: 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)
Time frame: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeon-Jeong Lee, PhD principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam premedication, Remifentanil infusion and Propofol infusion in people with Midazolam Premedication and Anxiety Preoperative, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in degree of anxiety (time frame: the anesthesiologist's visit on the day before surgery and pre-induction time after randomization). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.