NCT01558622

Brief Summary

The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

Enrollment Period

2 months

First QC Date

March 16, 2012

Last Update Submit

March 22, 2012

Conditions

Laparoscopic Nissen Fundoplication

Keywords

postoperative analgesiadexketoprofen trometamoltramadol hydrochloridepethidinelaparoscopic Nissen fundoplication

Outcome Measures

Primary Outcomes (1)

  • Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35

    postoperative 2 hours

Study Arms (6)

dexketoprofen trometamol

PLACEBO COMPARATOR

Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.

Drug: dexketoprofen trometamol

tramadol hydrochloride

PLACEBO COMPARATOR

Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.

Drug: tramadol hydrochloride

pethidine hydrochloride

PLACEBO COMPARATOR

Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared.

Drug: pethidine hydrochloride

dexketoprofen trometamol + tramadol hydrochloride

PLACEBO COMPARATOR
Drug: dexketoprofen trometamol + tramadol hydrochloride

dexketoprofen trometamol + pethidine hydrochloride

PLACEBO COMPARATOR
Drug: dexketoprofen trometamol + pethidine hydrochloride

vitamin c

PLACEBO COMPARATOR
Drug: vitamin c

Interventions

dexketoprofen trometamolDRUG

50mg intravenous infusion

dexketoprofen trometamol
tramadol hydrochlorideDRUG

100mg intravenous infusion

tramadol hydrochloride
pethidine hydrochlorideDRUG

50mg intravenous infusion

pethidine hydrochloride
dexketoprofen trometamol + tramadol hydrochlorideDRUG

intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride

dexketoprofen trometamol + tramadol hydrochloride
dexketoprofen trometamol + pethidine hydrochlorideDRUG

intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride

dexketoprofen trometamol + pethidine hydrochloride
vitamin cDRUG

500mg intravenous infusion

vitamin c

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old ASA I-II patients
  • Clinical diagnosis of gastroesophageal reflux patients

You may not qualify if:

  • Allergic reactions to NSAIDs or opioid analgesics
  • Body mass index exceeding 35
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kavaklidere Umut Hospital

Ankara, 06660, Turkey (Türkiye)

Location

MeSH Terms

Interventions

dexketoprofen trometamolTramadolMeperidineAscorbic Acid

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsIsonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydrates

Study Officials

  • GOKHAN GOKMEN, Specialist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, MD

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 20, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2012

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

TU(1)