Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: October 24, 2014
Last verified: October 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 rescue patient controlled propofol [ Time Frame: Up to 30 minutes during gastrointestinal endoscopy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Vitals signs will be assessed once intranasal dexmedetomidine is given

  • Recovery of patients [ Time Frame: Up to 3 hours after upper endoscopy ] [ Designated as safety issue: No ]
    Post-anesthetic discharge scores will be used.

  • Satisfaction of the patients [ Time Frame: Up to 5 hours after upper upper endoscopy ] [ Designated as safety issue: No ]
    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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 24, 2014
Health Authority: Hong Kong: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014