NCT04374318

Brief Summary

A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

March 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

April 28, 2020

Last Update Submit

May 6, 2020

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • First request to analgesia

    The first time the patient is asking for analgesia to control his pain

    Postoperative up to 24 hours

Secondary Outcomes (2)

  • Total postoperative analgesia consumption

    Postoperative up to 24 hours

  • visual analogue scale

    Every two hours for 24 hours postoperative

Study Arms (2)

IT intrathecal

ACTIVE COMPARATOR

administration of intrathecal dexmedetomidine in addition to bupivacaine for lower limb surgeries

Drug: Dexmedetomidine

IV intravenous

ACTIVE COMPARATOR

administration of intravenous dexmedetomidine in addition to spinal anaesthesia for lower limb surgeries

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

INTRATHECAL AND INTRAVENOUS

Also known as: precidex
IT intrathecalIV intravenous

Eligibility Criteria

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

You may qualify if:

  • ASA I-II patients
  • age 18-65 years
  • scheduled for lower limb surgery
  • spinal anaesthesia

You may not qualify if:

  • patients with coagulopathy
  • infection at the site of lumbar puncture
  • beta-blockers or calcium channel blockers usage
  • hypersensitivity to Bupivacaine or Dexmedetomidine
  • any other contra-indications for spinal anaesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Abdelrhman Alshawadfy, MD

    Suez Canal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 5, 2020

Study Start

March 1, 2019

Primary Completion

October 30, 2019

Study Completion

March 30, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)