Premedication for ERCP With Midazolam or Tramadol

Chronic Disease Clinical Trial

Official title:

Effects of Midazolam or Tramadol Premedication on Early Cognitive Function in ERCP: a Randomized Controlled Double-Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436980
• Other study ID #: 499
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2015
• Last updated: May 12, 2015
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2015
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde cholangiopancreatography) METHODS:This randomized and double blind study was performed with forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned. Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients who were randomly divided into two premedication groups.

Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was considered as cognitive impairment. Recovery period, post-procedure state of cognitive function at 60th minute were recorded.

Description:

The Outcome Measures are number of Participants with Adverse Events, and the incidence of Postoperative cognitive dysfunction assessed by MMT (mini-mental test) in first 60 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• This study was conducted in the Endoscopy Department for forty (18-70 years old) outpatients in ASA I-III risk group were randomized and double blind planned for elective ERCP.

Exclusion Criteria:

• American Society of Anesthesiologist (ASA) class greater than 3,

• morbid obesity,

• major organ dysfunction (respiratory, renal and hepatic),

• history of drug addiction,

• known hypersensitivity for tramadol, midazolam and remifentanil,

• mini-mental test (MMT) = 23 or

• refusal of the patient.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Drug:
• Tramadol
GROUP T
• Midazolam
GROUP M

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The early cognitive functions after ERCP	The early cognitive functions after ERCP assessed by mini-mental test (MMT)	Postprocedure in the first 60 minutes	Yes
Secondary	Number of Participants with Adverse Events	With any side effects	Postprocedure in first 60 minutes	Yes