Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery

NCT07522736 | Recruiting

• 1 other identifier: MD-70-2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the duration of analgesia (as the primary outcome) and adverse effects (as the secondary outcome) after intrathecal administration of dexmedetomidine with hyperbaric bupivacaine to patients undergoing knee orthopedic surgery.

Conditions

Intrathecal Dexmedetomidine; Bupivacaine; Knee Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

• Time to request rescue analgesia

  Time to request rescue analgesia will be recorded from the end of surgery to the first dose of morphine administrated

  24 hours postoperatively

Secondary Outcomes (4)

• Heart rate

  In the recovery room (Up to 2 hours)

• Mean arterial blood pressure

  In the recovery room (Up to 2 hours)

• Respiratory rate

  In the recovery room (Up to 2 hours)

• Oxygen saturation

  In the recovery room (Up to 2 hours)

Study Arms (3)

Group I

EXPERIMENTAL

Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg.

Drug: Dexmedetomidine 4 μg

Group II

EXPERIMENTAL

Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg.

Drug: Dexmedetomidine 8 μg

Group III

EXPERIMENTAL

Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg.

Drug: Dexmedetomidine 12 μg

Interventions

Dexmedetomidine 4 μg DRUG

Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg.

Group I

Dexmedetomidine 8 μg DRUG

Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg.

Group II

Dexmedetomidine 12 μg DRUG

Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg.

Group III

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Male patients scheduled for knee orthopedic surgery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Male patients scheduled for knee orthopedic surgery.

You may not qualify if:

• Patients with psychiatric disorders.
• History of drug addiction.
• Contraindication for regional anesthesia.
• History of hypersensitivity to the study drugs.
• Previous administration of opioids and/or other central nervous system depressants during current hospital admission.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ahmed A Ismail, MSc

CONTACT

00201115746779; ahmed.ali39348@postgrad.kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anaesthesia, Surgical ICU, and Pain, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)