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Safety and efficacy of ketamine-dexmedetomidine combination versus dexmedetomidine alone in cirrhotic patients undergoing upper gastrointestinal-intestinal endoscopy: A prospective controlled clinical trial.

Safety and Efficacy of Ketamine-dexmedetomidine versus dexmedetomidine alone in cirrhotic patients undergoing upper gastrointestinal endoscopy.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000367549
Enrollment
66
Registered
2015-04-22
Start date
2014-06-07
Completion date
2014-12-20
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Ketamine/ dexmedetomidine combination versus dexmedetomidine alone for procedural sedation in cirrhotic patients undergoing UGIE regarding efficacy and safety.

Interventions

GroupI(n=30):received I. V. Ketamine in a dose of 1 mg/ kg at induction of anesthesia followed by infusion of dexmedetomidine(dex) in a rate of 0.2-0.6ug/kg/hr till termination of endoscopy, while GroupII(n=30) received only a continuous infusion of dex. at induction of anesthesia in a rate of 0.2-0.6ug/kg/hr guided by BIS range of 50-70 till termination of endoscopy. In both groups,fentanyl 25 ug/ kg was used I.V as rescue sedoanalgesic when required

Sponsors

South valley university.
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Adult patients aged 18-60years with liver cirrhosis ,child-Pugh score A or B , referred for diagnostic and/ or therapeutic UGIE .

Exclusion criteria

Age less than 18 or more than 60 years, child- Pugh score C, need for emergency endoscopy ,hemodynamic ally unstable patients, significant cardio-pulmonary disease, hepatic encephalopathy,renal disease,use of sedatives or narcotics one week prior to the endoscopy time,anticipated airway difficulties, allergy to the used drugs.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026