Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery

Cairo University120 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Intrathecal Dexmedetomidine Bupivacaine Knee Orthopedic Surgery

Interventions

Dexmedetomidine 4 μgDRUG

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

Dexmedetomidine 8 μgDRUG

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

Dexmedetomidine 12 μgDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cairo University

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 24 hours postoperatively

Secondary Outcomes

Heart rate

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.

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

Mean arterial blood pressure

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.

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

Respiratory rate

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.

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

Oxygen saturation

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.

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

Central Contacts

Ahmed A Ismail, MSc

CONTACT

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

Data from ClinicalTrials.gov

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