NCT06082232

Brief Summary

The aim of this study is to compare the postoperative analgesic effect of intrathecal dexmedetomidine combined with bupivacaine and midazolam combined with bupivacaine in high tibial osteotomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Nov 2023

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

First Submitted

Initial submission to the registry

October 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 4, 2023

Last Update Submit

October 13, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Time to first analgesic request

    Time to first analgesic request calculated from the administration of local anesthetic

    24 hours

Secondary Outcomes (2)

  • analgesic consumption

    24 hours

  • Incidence of complications

    24 hours

Study Arms (3)

Group M (midazolam group)

ACTIVE COMPARATOR

includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 1 mg midazolam (8 units of 5 mg/mL preservative-free midazolam loaded in a 40 unit insulin syringe).

Drug: MidazolamDrug: Bupivacain

Group D(dexmedetomidine group)

ACTIVE COMPARATOR

includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 5 mcg dexmedetomidine (2 units of 100 mcg/mL preservative-free dexmedetomidine loaded in a 40 unit insulin syringe).

Drug: DexmedetomidineDrug: Bupivacain

Group C(control group)

PLACEBO COMPARATOR

includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 0.5 mL of 0.9% saline .

Drug: Bupivacain

Interventions

DexmedetomidineDRUG

Under strict aseptic conditions, a lumbar puncture will be performed with selective technique in sitting position at L2-3 or L3-4 interspaces with midline approach using a 25-G Quincke's needle. After achieving the free flow of cerebrospinal fluid, the study drug will be injected into the subarachnoid space, immediately after injection the patient will be asked for supine position.

Group D(dexmedetomidine group)
MidazolamDRUG

1 mg midazolam intrathecal administration

Group M (midazolam group)
BupivacainDRUG

20 mg bupivacaine intrathecal administration

Group C(control group)Group D(dexmedetomidine group)Group M (midazolam group)

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged 18-60 years.
  • Gender: Both males and females.
  • Scheduled patients for High tibial osteotomy under spinal anesthesia.
  • American Society of Anesthesiologists (ASA) physical status: I and II

You may not qualify if:

  • Patient refusal
  • Allergy to the studied drugs.
  • Patients with contraindications to spinal anesthesia.
  • Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases
  • Coagulopathy or thrombocytopenia
  • CNS diseases as epilepsy, stroke or psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.

    PMID: 17578977BACKGROUND

  • Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesth. 1995 Oct;42(10):891-903. doi: 10.1007/BF03011037.

    PMID: 8706199BACKGROUND

  • Kanazi GE, Aouad MT, Jabbour-Khoury SI, Al Jazzar MD, Alameddine MM, Al-Yaman R, Bulbul M, Baraka AS. Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiol Scand. 2006 Feb;50(2):222-7. doi: 10.1111/j.1399-6576.2006.00919.x.

    PMID: 16430546BACKGROUND

  • Mohler H, Okada T. Benzodiazepine receptor: demonstration in the central nervous system. Science. 1977 Nov 25;198(4319):849-51. doi: 10.1126/science.918669.

    PMID: 918669BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexmedetomidineMidazolamBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mohamed Youssef

    Assiut University

    STUDY CHAIR

  • Mahmoud Kamel

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Farghali

CONTACT

+201068914686ahmedsayedali2016@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 13, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 30, 2024

Last Updated

October 16, 2023

Record last verified: 2023-10