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Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 26, 2013
Last Update Posted: October 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cheung Chi Wai, The University of Hong Kong

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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Cheung Chi Wai, The University of Hong Kong:

Primary Outcome Measures:
  • Consumption of rescue patient controlled propofol [ Time Frame: Up to 30 minutes during gastrointestinal endoscopy ]
    Until the removal of the endoscopy from the patients

Secondary Outcome Measures:
  • Side effects of Intrananasal Dexmedetomidine [ Time Frame: Up to 24 hours after Upper Endoscopy ]
    Patients were asked the side effects up to 24 hours after upper endoscopy.

  • Observer's Assessment of Alertness/Sedation Scale (OAA/S) [ Time Frame: Up to 2 hours after upper endoscopy ]
    OAA/S will be assessed once intranasal dexmedetomidine is given

  • Vital signs including heart rate, systolic blood pressure and respiratory depression [ Time Frame: Up to 3 hours after upper endoscopy ]
    Vitals signs will be assessed once intranasal dexmedetomidine is given

  • Recovery of patients [ Time Frame: Up to 3 hours after upper endoscopy ]
    Post-anesthetic discharge scores will be used.

  • Satisfaction of the patients [ Time Frame: Up to 5 hours after upper upper endoscopy ]
    It will be asked upon discharge from hospital

Enrollment: 50
Study Start Date: January 2009
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)

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • American Society of Anesthesiology grade I-III
  • 18-60 years old
  • Patients having upper endoscopy

Exclusion Criteria:

  • Clinical history or electrocardiographic evidence of heart block, ischaemic - heart disease, asthma, sleep apnoea syndrome
  • BMI > 35kg/m2
  • Impaired liver (preoperative serum albumin level less than 30g/L ) or renal function (creatinine >120umol/L)) or known renal or hepatic disease
  • Alcohol consumption in excess of 28 units per week
  • Pregnancy
  • Patient refusal
  • Known psychiatric illness
  • Chronic sedative use, and regular use of or known allergy to dexmedetomidine, propofol and opioids.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887184

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

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
First Submitted: April 2, 2013
First Posted: June 26, 2013
Last Update Posted: October 28, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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