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Intramuscular Dexmedetomidine as Premedication

NCT ID: NCT01937611

Last Updated: 2013-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-10-31

Brief Summary

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Many studies have been conducted for the feasibility of using dexmedetomidine as premedication. However, bradycardia and hypotension frequently occurred following the premedication with dexmedetomidine, either via intramuscular or intravenous route. This is particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2 μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes. Most studies using high-dose dexmedetomidine were predominantly adopted with the dose-finding study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of intramuscular dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1 midazolam. However, few investigations have addressed the clinical effects of low-dose dexmedetomidine as premedication. Considering modern anaesthesia has advanced a long way towards eliminating the routine need for a deep preoperative sedation. It has, therefore, become desirable to asses dexmedetomidine as an effective premedication using a moderate sedative dose to minimize its undesired hemodynamic effects. We set a prospective study to compare the sedative, haemodynamic, adjuvant anaesthetic effects and patient's satisfaction of low-dose dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used premedication, used as an intramuscular injective administration in patients undergoing suspension laryngoscopic surgery under general anaesthesia.

Detailed Description

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Conditions

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Laryngoscopy Preanesthetic Medication

Keywords

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dexmedetomidine intramuscular premedication bradycardiac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine

dexmedetomidine 1μg•kg-1

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine

midazolam

midazolam 0.03 mg•kg-1

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam

Interventions

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Dexmedetomidine

Dexmedetomidine

Intervention Type DRUG

Midazolam

Midazolam

Intervention Type DRUG

Other Intervention Names

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Treatment control

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged 18-55 years old, American Society of Anaesthesiologists physical status I, scheduled for elective suspension laryngoscopic surgery of benign vocal fold lesions.

Exclusion Criteria

* Patients with neurological deficits
* Pregnancy
* Imprisonment
* Morbid obesity (body mass index ≥ 30 kg•m-2)
* Preoperative heart rate \<45 beats•min-1
* Second or third degree atrioventricular block
* Antihypertensive medication with α-methyldopa, clonidine or other α2-adrenergic agonist
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou First People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangcai Ruan

Professor, Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangcai Ruan, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University

Locations

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Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangcai Ruan, MD, PhD.

Role: CONTACT

Phone: +8620-81048306

Email: [email protected]

Huan Yang, MD.

Role: CONTACT

Phone: +8620-81048310

Email: [email protected]

Facility Contacts

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Jinhong Wang, Bs

Role: primary

References

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Jayaraman L, Sinha A, Punhani D. A comparative study to evaluate the effect of intranasal dexmedetomidine versus oral alprazolam as a premedication agent in morbidly obese patients undergoing bariatric surgery. J Anaesthesiol Clin Pharmacol. 2013 Apr;29(2):179-82. doi: 10.4103/0970-9185.111680.

Reference Type RESULT
PMID: 23878437 (View on PubMed)

Gupta K, Jain M, Gupta PK, Rastogi B, Saxena SK, Manngo A. Dexmedetomidine premedication for fiberoptic intubation in patients of temporomandibular joint ankylosis: A randomized clinical trial. Saudi J Anaesth. 2012 Jul;6(3):219-23. doi: 10.4103/1658-354X.101211.

Reference Type RESULT
PMID: 23162393 (View on PubMed)

Mowafi HA, Aldossary N, Ismail SA, Alqahtani J. Effect of dexmedetomidine premedication on the intraocular pressure changes after succinylcholine and intubation. Br J Anaesth. 2008 Apr;100(4):485-9. doi: 10.1093/bja/aen020. Epub 2008 Feb 19.

Reference Type RESULT
PMID: 18285392 (View on PubMed)

Peden CJ, Cloote AH, Stratford N, Prys-Roberts C. The effect of intravenous dexmedetomidine premedication on the dose requirement of propofol to induce loss of consciousness in patients receiving alfentanil. Anaesthesia. 2001 May;56(5):408-13. doi: 10.1046/j.1365-2044.2001.01553.x.

Reference Type RESULT
PMID: 11350323 (View on PubMed)

Taittonen MT, Kirvela OA, Aantaa R, Kanto JH. Effect of clonidine and dexmedetomidine premedication on perioperative oxygen consumption and haemodynamic state. Br J Anaesth. 1997 Apr;78(4):400-6. doi: 10.1093/bja/78.4.400.

Reference Type RESULT
PMID: 9135361 (View on PubMed)

Erkola O, Korttila K, Aho M, Haasio J, Aantaa R, Kallio A. Comparison of intramuscular dexmedetomidine and midazolam premedication for elective abdominal hysterectomy. Anesth Analg. 1994 Oct;79(4):646-53. doi: 10.1213/00000539-199410000-00006.

Reference Type RESULT
PMID: 7943770 (View on PubMed)

Virkkila M, Ali-Melkkila T, Kanto J, Turunen J, Scheinin H. Dexmedetomidine as intramuscular premedication for day-case cataract surgery. A comparative study of dexmedetomidine, midazolam and placebo. Anaesthesia. 1994 Oct;49(10):853-8. doi: 10.1111/j.1365-2044.1994.tb04257.x.

Reference Type RESULT
PMID: 7802178 (View on PubMed)

Sun Y, Liu C, Zhang Y, Luo B, She S, Xu L, Ruan X. Low-dose intramuscular dexmedetomidine as premedication: a randomized controlled trial. Med Sci Monit. 2014 Dec 18;20:2714-9. doi: 10.12659/MSM.891051.

Reference Type DERIVED
PMID: 25529851 (View on PubMed)

Other Identifiers

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20121A021007

Identifier Type: -

Identifier Source: org_study_id