Back to results

Premedication for ERCP With Midazolam or Tramadol

Primary Purpose

Chronic Disease

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Tramadol

Midazolam

About this trial

This is an interventional prevention trial for Chronic Disease focused on measuring premedication, ERCP, midazolam, tramadol, cognitive

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

tramadol

midazolam

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The early cognitive functions after ERCP

The early cognitive functions after ERCP assessed by mini-mental test (MMT)

Secondary Outcome Measures

Number of Participants with Adverse Events

With any side effects

Full Information

NCT ID

NCT02436980

First Posted

April 27, 2015

Last Updated

May 12, 2015

Sponsor

Karadeniz Technical University

1. Study Identification

Unique Protocol Identification Number

NCT02436980

Brief Title

Premedication for ERCP With Midazolam or Tramadol

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karadeniz Technical University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Disease

Keywords

premedication, ERCP, midazolam, tramadol, cognitive

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tramadol

Arm Type

Active Comparator

Arm Description

Arm Title

midazolam

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tramadol

Other Intervention Name(s)

CONTRAMAL

Intervention Description

GROUP T

Intervention Type

Drug

Intervention Name(s)

Midazolam

Other Intervention Name(s)

DORMICUM

Intervention Description

GROUP M

Primary Outcome Measure Information:

Title

The early cognitive functions after ERCP

Description

The early cognitive functions after ERCP assessed by mini-mental test (MMT)

Time Frame

Postprocedure in the first 60 minutes

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Description

With any side effects

Time Frame

Postprocedure in first 60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mehmet Arslan, Prof.Dr.

Organizational Affiliation

Gastroenterology Department

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Premedication for ERCP With Midazolam or Tramadol

We'll reach out to this number within 24 hrs