- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058485
Dexmedetomidine Premedication in Hypertensive Patients
Does the Use of Dexmedetomidine for Premedication Provide Hemodynamic Stability in Hypertensive Patients?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 140 female patients, aged 40-60, normotensive or stage 1-2 hypertensive, scheduled for myomectomy or hysterectomy were randomly enrolled to 4 groups: Group ND (normotensive-dexmedetomidine); Group HD (hypertensive-dexmedetomidine); group NM (normotensive-midazolam); Group HM (hypertensive- midazolam). Twenty-one patients were excluded. The study drugs were administered 15 min before induction of anesthesia via intravenous infusion. Group ND (N= 29) received dexmedetomidine 0.5 µg.kg-1 in normotensive patient; Group HD (N= 30) received dexmedetomidine 0.5 µg.kg-1 in hypertensive patient; group NM (N= 30) received midazolam 0.025 mg. kg-1 in normotensive patient; Group HM (N= 30) received midazolam 0.025 mg. kg-1 in hypertensive patient. The study drugs was prepared by the anesthetist not included in the study in unlabeled syringes that determined by computer according to the group. The investigators and attending anesthesiologists were blinded to the randomization. Monitoring devices included noninvasive arterial blood pressure, electrocardiography, capnography, pulse oximetry and bispectral index.
For induction of anesthesia with fentanyl 1 µg. kg-1 IV and propofol infusion was in the presence of BIS monitoring. Propofol infusion was stopped when BIS value was 60. Endotracheal intubation was performed after rocuronium 0.6 mg. kg-1 iv administered, Anesthesia was maintained with sevoflurane in air/oxygen 50:50 mixture, titrated to achieve a BIS value between 40 and 60. If the MBP value was increased > 25% of the baseline value on two consecutive readings within 2-3 min, antihypertensive therapy was administered (nitroglycerine 5 µg.min-1 iv infusion) after excluded possible cause ( inadequate anesthesia, hypoxia, hypercapnia etc). Bradycardia ( HR< 45 beat/min) persisting for > 2 min was treated with atropine 0.5 mg IV, boluses. At the end of the surgery sevoflurane turned off, and 100% oxygen was administered. Tramadol 1 mg.kg-1 IV was administered for postoperative pain control. Neuromuscular block was antagonized with neostigmine (0.04 mg.kg-1 IV) and atropine (0.01 mg.kg-1 IV). Tracheal extubation was performed when obeying simple commands (open eye, squeeze hand etc) Systolic blood pressure (SBP), diastolic blood pressure ( DBP), mean blood pressure ( MBP) and heart rate ( HR) were recorded at several times as follows: baseline (T0 ), 5 minutes after administration of study drugs (T1), 10 minutes after administration of study drugs (T2), immediately after induction (T3), 1 minute after intubation (T4), 5 minute after intubation (T5), at surgical incision (T6), 15 minutes after surgical incision (T7), 30 minutes after surgical incision (T8), 1 minute after extubation (T9), 5 minute after extubation (T10). Propofol amount for induction, time between induction and initial surgery, demand of antihypertensive therapy, rescue atropine were recorded. Side effects (bradycardia, dryness of the mouth, respiratory depression) were evaluated.
The group sizes (N= 30) were calculated to detect a 25% changes in MBP value with a power of 80% and a significance level of 0.05. Quantitative clinical and demographic characteristics were compared using One Way ANOVA. Chi-square tests (Likelihood ratio or Pearson) were used to examine the relationships between categorical demographic data and groups. Baseline measurements of hemodynamic parameters showed significant differences between groups for the initial values of the measurement period values have been adjusted by subtracting the beginning. The values obtained after the correction in respect of groups were compared using one-way analysis of variance. In addition, perioperative use of antihypertensive drugs that affect the measurements were evaluated by analysis of co-variance, but there is not significant effect was removed from the model. Additionally periodic variations were examined by One way Repeated Measures Analysis of Variance for groups separately, and a significance level of 0.05.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Duzce, Turkey, 81620
- Duzce University Medicine School, Anesthesiology and Reanimation Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Normotensive
- Hypertension with stage 1 or 2
- Scheduled for myomectomy or hysterectomy operation
- Aged 40-60
- ASA I or II
- BMI is under 30 kg/m2
Exclusion Criteria:
- Untreated hypertension
- Users of ACE inhibitors as antihypertensive therapy
- History of severe cardiovascular disease, renal disease, diabetes mellitus, cerebrovascular disease
- An allergy to study drugs
- Difficult airway
- If the time more than fifteen minutes between the start of surgery and the induction
- If necessary blood transfusion was required
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group HD
Dexmedetomidine was administered 0.5 µg.kg-1 in hypertensive patient
|
Dexmedetomidine was calculated by actual body weight of patients that had been diluted with saline to 40 ml.
Dexmedetomidine was administered 15 min before induction of anesthesia via intravenous infusion.
at a dose of 0.5 µg.kg-1
Other Names:
|
Sham Comparator: Group ND
Dexmedetomidine was administered 0.5 µg.kg-1 in normotensive patient
|
Dexmedetomidine was calculated by actual body weight of patients that had been diluted with saline to 40 ml.
Dexmedetomidine was administered 15 min before induction of anesthesia via intravenous infusion.
at a dose of 0.5 µg.kg-1
Other Names:
|
Active Comparator: Group HM
Midazolam was administered 0.025 mg.
kg-1 in hypertensive patient.
|
Midazolam was calculated by actual body weight of patients that had been diluted with saline to 40 ml.
It was administered 15 min before induction of anesthesia via intravenous infusion.
at a dose of 0.025 mg.kg-1
Other Names:
|
Sham Comparator: Group NM
Midazolam was administered 0.025 mg.
kg-1 in normotensive patient.
|
Midazolam was calculated by actual body weight of patients that had been diluted with saline to 40 ml.
It was administered 15 min before induction of anesthesia via intravenous infusion.
at a dose of 0.025 mg.kg-1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peroperative hemodynamic changes
Time Frame: 2 hours
|
Systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate were recorded at baseline ( T0),5 minutes after administration of study drugs (T1), 10 minutes after administration of study drugs (T2), immediately after induction (T3), 1 minute after intubation (T4), 5 minute after intubation (T5), at surgical incision (T6), 15 minutes after surgical incision (T7), 30 minutes after surgical incision (T8), 1 minute after extubation (T9), 5 minute after extubation (T10).
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
antihypertensive requirements
Time Frame: 2 hours
|
If the mean blood pressure value was increased > 25% of the baseline value on two consecutive readings within 2-3 min, antihypertensive therapy was administered.
The patients used antihypertensive were recorded.
|
2 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Propofol amount
Time Frame: 2 hours
|
Propofol amount for induction
|
2 hours
|
rescue atropine
Time Frame: 2 hours
|
Bradycardia ( HR< 45 beat/min) persisting for > 2 min was treated with atropine 0.5 mg IV, boluses.
This patients were recorded.
|
2 hours
|
Side effects
Time Frame: 2 hours
|
bradycardia, dryness of the mouth, respiratory depression were evaluated.
|
2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gulbin Sezen, Duzce University
- Principal Investigator: Yavuz Demiraran, Duzce University
Publications and helpful links
General Publications
- Kunisawa T, Nagata O, Nagashima M, Mitamura S, Ueno M, Suzuki A, Takahata O, Iwasaki H. Dexmedetomidine suppresses the decrease in blood pressure during anesthetic induction and blunts the cardiovascular response to tracheal intubation. J Clin Anesth. 2009 May;21(3):194-9. doi: 10.1016/j.jclinane.2008.08.015.
- Menda F, Koner O, Sayin M, Ture H, Imer P, Aykac B. Dexmedetomidine as an adjunct to anesthetic induction to attenuate hemodynamic response to endotracheal intubation in patients undergoing fast-track CABG. Ann Card Anaesth. 2010 Jan-Apr;13(1):16-21. doi: 10.4103/0971-9784.58829.
- Basar H, Akpinar S, Doganci N, Buyukkocak U, Kaymak C, Sert O, Apan A. The effects of preanesthetic, single-dose dexmedetomidine on induction, hemodynamic, and cardiovascular parameters. J Clin Anesth. 2008 Sep;20(6):431-6. doi: 10.1016/j.jclinane.2008.04.007.
- Sezen G, Demiraran Y, Seker IS, Karagoz I, Iskender A, Ankarali H, Ersoy O, Ozlu O. Does premedication with dexmedetomidine provide perioperative hemodynamic stability in hypertensive patients? BMC Anesthesiol. 2014 Dec 10;14:113. doi: 10.1186/1471-2253-14-113. eCollection 2014.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
- Dexmedetomidine
Other Study ID Numbers
- Duzce-2011/160
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