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HypertensionPhase 3NCT02058485

Dexmedetomidine Premedication in Hypertensive Patients

A Phase 3 study testing Midazolam and Dexmedetomidine in people with Hypertension, run by Duzce University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypertensive patients' often severe hypotensive response after induction of anesthesia and excessive increase in blood pressure to stresses such as laryngoscopy, intubation, surgical incision and extubation. Read more about this study

Who is it for?
Ages 40 to 60 years, women only
Conditions the study is for
Hypertension
What is being tested?
Midazolam and Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
1 siteTurkey (Türkiye)
Study dates
Jan 2012to Jun 2013
Phase
Phase 3
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 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Duzce University Medicine School, Anesthesiology and Reanimation Department

    Düzce, 81620

Other trials in Turkey (Türkiye)

About this study

Official title: Does the Use of Dexmedetomidine for Premedication Provide Hemodynamic Stability in Hypertensive Patients?

Hypertensive patients' often severe hypotensive response after induction of anesthesia and excessive increase in blood pressure to stresses such as laryngoscopy, intubation, surgical incision and extubation. There are many publications in the literature of preoperative evaluation of patients with hypertension and perioperative treatment of hypertension but is not sufficient about anesthetic management of these patients. Purpose of our study, was to investigate the haemodynamic effects of dexmedetomidine and midazolam used for premedication in hypertensive patients relative to each other and according to the normotensive patients.

Read the 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.

Conditions
Hypertension
Keywords
hypertension, dexmedetomidine, midazolam, premedication
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MidazolamDrug

    Also called Dormicum

    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

  • DexmedetomidineDrug

    Also called Precedex

    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

Study groups in NCT02058485
Study groupRoleWhat they receive
Group HDActive comparatorDexmedetomidine was administered 0.5 µg.kg-1 in hypertensive patient
Receives: Drug: Dexmedetomidine
Group NDSham comparatorDexmedetomidine was administered 0.5 µg.kg-1 in normotensive patient
Receives: Drug: Dexmedetomidine
Group HMActive comparatorMidazolam was administered 0.025 mg. kg-1 in hypertensive patient.
Receives: Drug: Midazolam
Group NMSham comparatorMidazolam was administered 0.025 mg. kg-1 in normotensive patient.
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. peroperative hemodynamic changes

    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).

    Measured: 2 hours

Secondary outcomes (1)
  1. antihypertensive requirements

    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.

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2014 (estimated)
  2. Study startJan 2012
  3. Primary completionApr 2013
  4. Study completionJun 2013

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02058485
Sponsor's protocol ID
Duzce-2011/160
Status last verified
Feb 2014
First submitted
6 Feb 2014
Last updated
10 Feb 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 19464613
  • 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.

    PubMed 20075530
  • 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.

    PubMed 18929283
  • 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.

    PubMed 25550680

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Midazolam and Dexmedetomidine in people with Hypertension, run by Duzce University at 1 site in Turkey (Türkiye).

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 6 inclusion and 7 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 10 Feb 2014. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

peroperative hemodynamic changes (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02058485, which also lists 4 linked publications.

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 10 Feb 2014.

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