Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07522736

Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intrathecal Dexmedetomidine Bupivacaine Knee Orthopedic Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Ahmed A Ismail, MSc

CONTACT

[email protected]

00201115746779

Ayman A Abougabal, MD

SUB_INVESTIGATOR

Dalia K Abdelkader, MD

SUB_INVESTIGATOR

Osama M Asaad, MD

SUB_INVESTIGATOR

Sheerin R Hamza, MD

SUB_INVESTIGATOR

About this study

Intrathecal adjuncts are commonly added to local anesthetic agents, to improve the duration of nerve blocks and postoperative pain relief without increasing the dosage of local anesthetic.

Studies have shown that dexmedetomidine (DEX) has a greater potential for enhancing analgesic effects due to its higher specificity for alpha2 adrenoceptors. DEX is commonly used for sedation and as an adjunct to reduce the amount of anesthesia and opioids required during general and regional anesthesia in both adults and children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine 4 μg

Drug

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

Dexmedetomidine 8 μg

Drug

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

Dexmedetomidine 12 μg

Drug

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

Primary outcomes

  1. Time to request rescue analgesia

    Time frame: 24 hours postoperatively

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

Secondary outcomes

  1. Heart rate

    Time frame: In the recovery room (Up to 2 hours)

    Heart rate will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.

  2. Mean arterial blood pressure

    Time frame: In the recovery room (Up to 2 hours)

    Mean arterial blood pressure will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.

  3. Respiratory rate

    Time frame: In the recovery room (Up to 2 hours)

    Respiratory rate will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.

  4. Oxygen saturation

    Time frame: In the recovery room (Up to 2 hours)

    Oxygen saturation will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Ismail, MSc

CONTACT

[email protected]

00201115746779

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Analgesic Effect of Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery: A Randomized Double-Blinded Dose-Finding Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.