Premedication for ERCP With Midazolam or Tramadol

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02436980

Enrollment

Registered

2015-05-07

Start date

2009-01-31

Completion date

2009-12-31

Last updated

2015-05-13

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

Conditions

Chronic Disease

Keywords

premedication, ERCP, midazolam, tramadol, cognitive

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.

Interventions

DRUGTramadol

GROUP T

DRUGMidazolam

GROUP M

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The early cognitive functions after ERCP	Postprocedure in the first 60 minutes	The early cognitive functions after ERCP assessed by mini-mental test (MMT)

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events	Postprocedure in first 60 minutes	With any side effects

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026