Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine 4 μg, Dexmedetomidine 8 μg, Dexmedetomidine 12 μg.
- Who it may be relevant to
- Registry conditions: Intrathecal Dexmedetomidine, Bupivacaine, Knee Orthopedic Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Analgesic Effect of Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery: A Randomized Double-Blinded Dose-Finding Trial
Overview
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.
Detailed description
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.
Interventions
- Drug Dexmedetomidine 4 μg
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg. - Drug Dexmedetomidine 8 μg
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg. - Drug Dexmedetomidine 12 μg
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg.
Primary outcome measures
- Time to request rescue analgesia [Time frame: 24 hours postoperatively]
Secondary outcome measures (4)
- Heart rate [Time frame: In the recovery room (Up to 2 hours)]
- Mean arterial blood pressure [Time frame: In the recovery room (Up to 2 hours)]
- Respiratory rate [Time frame: In the recovery room (Up to 2 hours)]
- Oxygen saturation [Time frame: In the recovery room (Up to 2 hours)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07522736 · MD-70-2025