NCT02619019

Brief Summary

Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it extended the duration of analgesia. We aim to study the effectiveness of spinal dexamethasone in Transuretheral prostatectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

November 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

November 27, 2015

Last Update Submit

September 13, 2016

Conditions

Postspinal Shivering

Outcome Measures

Primary Outcomes (1)

  • Shivering

    by shivering score

    150 min after spinal anesthesia

Secondary Outcomes (3)

  • Mean arterial blood pressure

    150 min after spinal anesthesia

  • Heart rate

    150 min after spinal anesthesia

  • Core temperature

    150 min after spinal anesthesia

Study Arms (3)

Dexamethasone group

ACTIVE COMPARATOR

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally

Drug: Dexamethasone

Pethidine group

ACTIVE COMPARATOR

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally

Drug: Pethidine

Control group

PLACEBO COMPARATOR

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally

Drug: Normal saline

Interventions

DexamethasoneDRUG

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally

Dexamethasone group
PethidineDRUG

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally

Also known as: Mepredine
Pethidine group
Normal salineDRUG

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally

Control group

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 50-75 yr ASA class I,II, and III undergoing Transuretheral prostatectomy under spinal anesthesia

You may not qualify if:

  • Contraindications to spinal anesthesia, Allergy to the study medication, Thyroid disease, Parkinson's disease Patients receiving vasodilators or medications likely to alter thermoregulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seham Mohamed Moeen Ibrahim

Asyut, Asyut Governorate, 71111, Egypt

Location

MeSH Terms

Interventions

DexamethasoneMeperidineSaline Solution

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedIsonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Seham M Moeen, MD

    Assiut Univerisity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 2, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

EG(1)