Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy

NCT01887184 | Completed Phase 3 Results

• 1 other identifier: UW 07-212
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastrointestinal Disease

Outcome Measures

Primary Outcomes (1)

• Consumption of Rescue Patient Controlled Propofol

  Until the removal of the endoscopy from the patients

  Up to 30 minutes during gastrointestinal endoscopy

Secondary Outcomes (1)

• Side Effects of Intrananasal Dexmedetomidine

  Up to 24 hours after Upper Endoscopy

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Normal saline was given intranasally

Drug: Placebo

Dexmedetomidine

ACTIVE COMPARATOR

1.5mcg dexmedetomidine was given intranasally before procedure

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine 1.5mcg/kg was given intranasally

Also known as: Dexmedetomidine (Hospira)

Dexmedetomidine

Placebo DRUG

Intranasal saline was given

Normal Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Professor Chi Wai Cheung
• Organization: The University of Hong Kong

cheucw@hku.hk

22553303

Study Officials

• Chi Wai Cheung, MBBS, MD

  Department of Anaesthesiology, the University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: June 26, 2013
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2024-07