Bupivacaine, Intrathecal Dexmedetomidine, Knee Orthopedic Surgery
Conditions
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.
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
DRUGDexmedetomidine 4 μg
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg.
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg.
DRUGDexmedetomidine 12 μg
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to request rescue analgesia | 24 hours postoperatively | Time to request rescue analgesia will be recorded from the end of surgery to the first dose of morphine administrated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 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. |
| Mean arterial blood pressure | 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. |
| Respiratory rate | 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. |
| Oxygen saturation | 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. |
Countries
Egypt
Contacts
CONTACTAhmed A Ismail, MSc
Outcome results
None listed