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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002495-18-GB

Enrollment

Registered

2006-10-31

Start date

2007-04-08

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Ketalar Pharmaceutical Form: Solution for injection INN or Proposed INN: KETAMINE HYDROCHLORIDE CAS Number: 1867669 Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate in a pilot study the safety and effectiveness during sedation for endoscopic retrograde cholangiopancreatography of the arylcyclohexylamine drug ketamine used in combination with midazolam, as compared to the standard combination of midazolam with pethidine. ; Secondary Objective: To demonstrate the use of side-stream capnography as an adjunct to standard monitoring during sedation for endoscopic retrograde cholangiopancreatography. ;Primary end point(s): The trial will end when 40 to 60 patients have been recruited, approximately half to the study arm of sedation with ketamine and midazolam and approximately half to the control arm of conventional sedation with pethidine and midazolam.	—

Measure

Time frame

Main Objective: To demonstrate in a pilot study the safety and effectiveness during sedation for endoscopic retrograde cholangiopancreatography of the arylcyclohexylamine drug ketamine used in combination with midazolam, as compared to the standard combination of midazolam with pethidine. ; Secondary Objective: To demonstrate the use of side-stream capnography as an adjunct to standard monitoring during sedation for endoscopic retrograde cholangiopancreatography. ;Primary end point(s): The trial will end when 40 to 60 patients have been recruited, approximately half to the study arm of sedation with ketamine and midazolam and approximately half to the control arm of conventional sedation with pethidine and midazolam.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026