Dexmedetomidine Premedication in Hypertensive Patients

NCT02058485 | Completed Phase 3

• 1 other identifier: Duzce-2011/160
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension

Keywords

hypertension; dexmedetomidine; midazolam; premedication

Outcome Measures

Primary Outcomes (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).

  2 hours

Secondary Outcomes (1)

• antihypertensive requirements

  2 hours

Other Outcomes (3)

• Propofol amount

  2 hours

• rescue atropine

  2 hours

• Side effects

  2 hours

Study Arms (4)

Group HD

ACTIVE COMPARATOR

Dexmedetomidine was administered 0.5 µg.kg-1 in hypertensive patient

Drug: Dexmedetomidine

Group ND

SHAM COMPARATOR

Dexmedetomidine was administered 0.5 µg.kg-1 in normotensive patient

Drug: Dexmedetomidine

Group HM

ACTIVE COMPARATOR

Midazolam was administered 0.025 mg. kg-1 in hypertensive patient.

Drug: Midazolam

Group NM

SHAM COMPARATOR

Midazolam was administered 0.025 mg. kg-1 in normotensive patient.

Drug: Midazolam

Interventions

Midazolam DRUG

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

Also known as: Dormicum

Group HM; Group NM

Dexmedetomidine DRUG

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

Also known as: Precedex

Group HD; Group ND

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Medicine School, Anesthesiology and Reanimation Department

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 19464613 RESULT

• 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.

  PMID: 20075530 RESULT

• 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.

  PMID: 18929283 RESULT

• 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.

  PMID: 25550680 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Midazolam; Dexmedetomidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Gulbin Sezen

  Duzce University

  STUDY DIRECTOR

• Yavuz Demiraran

  Duzce University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant of professor

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

TU (1)