Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia

NCT02522858 | Completed Phase 4

• 1 other identifier: IIT-2015-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to prolong the anesthesia time when used with patients undergoing spinal anesthesia. However, dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication of anticholinergic agents on vital sign in patients undergoing spinal anesthesia.

Conditions

Bradycardia

Keywords

premedication; dexmedetomidine; anesthesia, spinal

Outcome Measures

Primary Outcomes (1)

• The incidence of bradycardia

  The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously.

  30miniutes from starting dexmedetomidine with loading dose

Secondary Outcomes (1)

• The incidence of hypotension

  30miniutes from starting dexmedetomidine with loading dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, normal saline 0.5mL would be injected intravenously.

Drug: Dexmedetomidine; Drug: Ephedrine

Atropine

EXPERIMENTAL

After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, ,atropine 0.03mg/kg would be injected intravenously.

Drug: Atropine; Drug: Dexmedetomidine; Drug: Ephedrine

Interventions

Atropine DRUG

To evaluate the effectiveness of atropine on prevention bradycardia,atropine 0.01\~0.03mg/kg up to 0.5mg would be injected intravenously just before starting loading dose of dexmedetomidine in group A. During operation, heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. This intervention would be applied to both group.

Atropine

Dexmedetomidine DRUG

Dexmedetomidine is a highly selective a2 adrenergic receptor antagonist used as sedative agent. After confirming the fixation level of spinal anesthesia, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/mL would be started for 10 minutes.Maintenance dose(0.25ug/kg/hr) would be continued after loading dose.

Atropine; Placebo

Ephedrine DRUG

Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously.

Atropine; Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergoing spinal anesthesia with sedation over 19 years old.

You may not qualify if:

• Patients who are contraindicated of spinal anesthesia such as hypovolemic status, coagulation disorder, infection of tapping site, pregnancy, heart problem, history of drug allergy, drug abuser, anemia, headache and medication of antipsychotic drugs.
• Patiensts who are contraindicated of atropine such as glaucoma, voiding difficulty due to prostate hyperplasia, heart disease, ulcerative colitis, hyperthyroidism and fever.

Sponsors & Collaborators

• Sira Bang: lead

Study Sites (1)

Inje University Seoul Paik Hospital, Seoul, Korea

Seoul, Jung-Gu,, 100-032, South Korea

Location

MeSH Terms

Conditions

Bradycardia

Interventions

Atropine; Dexmedetomidine; Ephedrine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Sira Bang, MD PhD

  Inje University Seoul Paik Hospital, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Seoul Paik Hospital, Seoul, Korea

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

KR (1)