The use of ketamine in combination with midazolam for the induction of conscious sedation during endoscopic retrograde cholangiopancreatography (ERCP). - Alternative sedation in endoscopy.

Phase 1

• Conditions: The study will not investigate any specific disease, but rather the sedation techniques used for endoscopic retrograde cholangiopancreatography, a form of endoscopy which can be used to diagnose and treat many types of biliary disease.; MedDRA version: 8.1 Level: LLT Classification code 10014802 Term: Endoscopic retrograde cholangiopancreatography

• Registration Number: EUCTR2006-002495-18-GB
• Lead Sponsor: Wrightington, Wigan and Leigh NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

All patients of American Society of Anaesthesiologists (ASA) Classes 1-3 listed for endoscopic retrograde cholangiopancreatography will initially be considered for the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Confusion or dementia to a level where incapable of giving informed
consent
2.Comprehension of English at a level where incapable of giving direct
informed consent
3.Already participated in the study or refused to participate previously
4.Significant chest infection or disease
5.Known or likely to be difficult to mask ventilate or to have a difficult
airway
6.Pulmonary hypertension
7.History of apnoea / obstructive sleep apnoea
8.Intracranial hypertension (CNS mass lesion, head injury associated with
increased ICP)
9.Head injury with loss of consciousness, altered mental status or emesis
10.Pregnant and nursing women
11.Acute eye injury
12.Untreated increased intraocular pressure
13.History of bipolar disease / schizophrenia
14.Age under 18
15.Prior adverse reactions to ketamine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified