NCT02436980

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

April 27, 2015

Last Update Submit

May 12, 2015

Conditions

Chronic Disease

Keywords

premedicationERCPmidazolamtramadolcognitive

Outcome Measures

Primary Outcomes (1)

  • The early cognitive functions after ERCP

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

    Postprocedure in the first 60 minutes

Secondary Outcomes (1)

  • Number of Participants with Adverse Events

    Postprocedure in first 60 minutes

Study Arms (2)

tramadol

ACTIVE COMPARATOR

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.

Drug: Tramadol

midazolam

ACTIVE COMPARATOR

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.

Drug: Midazolam

Interventions

TramadolDRUG

GROUP T

Also known as: CONTRAMAL
tramadol
MidazolamDRUG

GROUP M

Also known as: DORMICUM
midazolam

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Disease

Interventions

TramadolMidazolam

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mehmet Arslan, Prof.Dr.

    Gastroenterology Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.Dr.

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 7, 2015

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

May 13, 2015

Record last verified: 2015-05