Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cheung Chi Wai, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01887184
First received: April 2, 2013
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may be associated with discomfort. Although upper endoscopy is usually of shorter duration and better tolerated by patients, most trials investigating the influence of analgesia and sedation have been performed on patients undergoing this procedure. Some patients may tolerate colonoscopy without sedation, but various techniques are used to limit discomfort and pain. Selection and dosing of sedatives depends on the patient's emotional state, the intensity of pain during examination, foreseeable technical difficulties, the endoscopist's experience, the presence or absence of anesthesia personnel, and hospital-specific procedures.

Conscious sedation is a popular technique for colonoscopy and upper gastrointestinal endoscopy. The combination of an opioid and a benzodiazepine is known to provide good analgesic and sedative conditions during endoscopy. This combination of opioid and benzodiazepine, however, also increases the risk of respiratory depression. Therefore, pharmacologic agents which may provide adequate sedation without respiratory depression are of great interest to clinicians.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative and analgesic effects. Compared with clonidine, it is more selective for the α 2 adrenoceptor and acts as a full agonist in most pharmacologic test models. Potentially desirable properties include decreased requirements for other anesthetics and analgesics, a diminished sympathetic response to stress and the potential for cardioprotective effects against myocardial ischemia. When compared with conventional sedatives such as opioids or benzodiazepines, its lack of respiration depression is a distinct advantage. Previous studies using dexmedetomidine for sedation has been promising with maintenance of respiratory function. Patients are readily arousable. With intravenous slow bolus administration, there is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. Many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children.


Condition Intervention Phase
Gastrointestinal Disease
Drug: Dexmedetomidine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Assess Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Consumption of propofol [ Time Frame: Up to 30 minutes during gastrointestinal endoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects of Intrananasal Dexmedetomidine [ Time Frame: Up to 24 hours after Upper Endoscopy ] [ Designated as safety issue: No ]
    Patients were asked the side effects up to 24 hours after upper endoscopy.


Enrollment: 50
Study Start Date: June 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline
Normal saline was given intranasally
Active Comparator: Dexmedetomidine
1.5mcg dexmedetomidine was given intranasally before procedure
Drug: Dexmedetomidine
Dexmedetomidine 1.5mcg/kg was given intranassaly
Other Name: Dexmedetomidine (Hospira)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiology grade I-III
  • 18-60 years old

Exclusion Criteria:

  1. Pregnancy
  2. Mentally unfit
  3. History of colon surgery and gastric surgery
  4. Current or chronic use of α2 agonist
  5. Allergy or previous adverse reaction to any medication used in this study
  6. Addiction to opioids, sedatives, illicit drugs or alcohol
  7. Patient refusal
  8. Impaired renal (Cr>120umol/L)or hepatic function (preoperative serum albumin level less than 30g/L) or known renal or hepatic disease
  9. Exposure to study drug within the past 3 months
  10. Pre-existing heart block or other conduction defect
  11. Known history of sleep apnoea syndrome
  12. BMI > 35kg/m2
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01887184

Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Chi Wai Cheung, MBBS, MD Department of Anaesthesiology, the University of Hong Kong
  More Information

No publications provided

Responsible Party: Cheung Chi Wai, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01887184     History of Changes
Other Study ID Numbers: UW 07-212
Study First Received: April 2, 2013
Last Updated: February 26, 2014
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014