NCT03164590

Brief Summary

This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

May 22, 2017

Last Update Submit

January 19, 2020

Conditions

Endometrial Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • severity of pain at rest and on coughing

    severity of pain at rest and on coughing will be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 = worst imaginable pain)

    24 hours

Secondary Outcomes (1)

  • sedation

    24 hours

Study Arms (3)

ketamine

ACTIVE COMPARATOR
Drug: Ketamine

dexmedetomidine

ACTIVE COMPARATOR
Drug: dexmedetomidine

bupivacaine

PLACEBO COMPARATOR
Drug: KetamineDrug: dexmedetomidineDrug: bupivacaine

Interventions

KetamineDRUG

patients receive local anesthetic wound infiltration with 1 mg /kg ketamine

bupivacaineketamine
dexmedetomidineDRUG

patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine

bupivacainedexmedetomidine
bupivacaineDRUG

patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline

bupivacaine

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II patients
  • age range (18-60) years,
  • weight (50- 90) kg

You may not qualify if:

  • allergy to study drugs
  • significant cardiac disease
  • respiratory disease
  • renal disease
  • hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer instIitute

Asyut, 171516, Egypt

Location

MeSH Terms

Interventions

KetamineDexmedetomidineBupivacaine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesAniline CompoundsAmines

Study Officials

  • fatma el sherif, MD

    South Egypt Cancer Institute

    PRINCIPAL INVESTIGATOR

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
lecturer of anesthesia ,ICU and pain releif

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 23, 2017

Study Start

June 1, 2017

Primary Completion

August 1, 2018

Study Completion

September 1, 2018

Last Updated

January 22, 2020

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)