Premedication for ERCP With Midazolam or Tramadol

NCT ID: NCT02436980

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-12-31

Brief 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.

Detailed 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.

Conditions

Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

tramadol

1mg/kg of tramadol drop (Contramal® drop, Abdi Ibrahim Ilaç San.,istanbul) was administered orally in 10 mL of cherry juice without particles in preparation room before intervention, Group T who were separated randomly to two premedication groups.

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

GROUP T

midazolam

0.15 mg/kg of midazolam (Dormicum®, ampoule, Roche Products A.Ş., istanbul) was administered orally in 10 mL of cherry juice without particles in preparation room before intervention, to Group M who were separated randomly to two premedication groups.

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

GROUP M

Interventions

Tramadol

GROUP T

Intervention Type: DRUG

Midazolam

GROUP M

Intervention Type: DRUG

Other Intervention Names

CONTRAMAL; DORMICUM

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Hulya ULUSOY

Assoc.Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Arslan, Prof.Dr.

Role: STUDY_CHAIR

Gastroenterology Department

Other Identifiers

499

Identifier Type: -

Identifier Source: org_study_id