Clinical trial NCT02660658: Optimal Single Dose Intrathecal Dexmedetomidine for Postoperative Analgesia
Official title: Optimal Single-dose Intrathecal Dexmedetomidine for Postoperative Analgesia After Lower Limb Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Spinal anesthesia is a commonly used technique for lower limb surgeries offering better quality of postoperative analgesia, lower incidence of side effects, and shorter post-anesthesia care unit stay than general anesthesia. However, the relatively short duration of action of the currently available local anesthetics (LAs) make these advantages short-lived.

The risk for local anesthetic toxicity (LAST) increases with the trials to use higher concentrations or volumes of intrathecal local anesthetics to increase the duration of analgesia.

Dexmedetomidine has the potential to prolong the duration of perioperative analgesia without the need for using high doses of local anesthetics and hence with decreasing the potential risk of local anesthetic, but the increased likelihood adverse effects such as short term bradycardia and prolonged duration of motor block may offset these benefits.

Detailed description: The aim of this study is to determine the optimal single-dose of intrathecal dexmedetomidine that prolongs the analgesic duration with the least possible side effects.

With the patients in the sitting position and the use of complete aseptic technique, 25G Whitacre spinal needles will be introduced through L2-L4 interspaces and after observing free flow of the CSF, a 3ml volume including bupivacaine 12.5mg in conjunction with dexmedetomidine (3 µg) will be injected in the first case, then the patient will be turned supine.

The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical class I to II.
* Patients scheduled for elective lower limb surgeries.

Exclusion Criteria:

* Morbid obese patients.
* Severe or uncompensated cardiovascular disease.
* Significant renal disease.
* Significant hepatic disease.
* Pregnancy.
* Lactating .
* Heart block.
* Bradyarrhythmias.
* Receiving adrenergic receptor antagonist medications.
* Receiving calcium channel blockers.
* Patients with pacemakers.
* Patients with implanted cardioverter defibrillator.
* Allergy to the study medications.
* Psychological disease.
* Neurological disorders.
* Communication barrier.
* Mental disorders.
* Epilepsy.
* Drug or alcohol abuse.
* Contraindications to spinal anaesthesia.
* Receiving opioid analgesic medications within 24 h before the operation.

Primary outcomes:
measure: Duration of analgesia
timeFrame: For 13 hours after surgery
Secondary outcomes:
measure: Postoperative pain score
timeFrame: For 24 hours after surgery
measure: Onset of sensory blockade
timeFrame: For 1 hour after initiaion of spinal anesthesia
measure: Onset of motor blockade
timeFrame: For 2 hours after initiation of spinal anesthesia
measure: Highest dermatome level of sensory blockade
timeFrame: For 4 hours after initiation of spinal anesthesia
measure: Time to motor regression
timeFrame: For 6 hours after initiation of spinal anesthesia
measure: Sedation score
timeFrame: For 24 hours after initiation of spinal anesthesia
measure: Postoperative nausea and vomiting
timeFrame: For 24 hours after initiation of spinal anesthesia
measure: Cumulative tramadol consumption
timeFrame: For 24 hours after surgery
measure: Intraoperative bradycardia
timeFrame: For 4 hours after initiation of spinal anesthesia
measure: Intraoperative use of ephedrine
timeFrame: For 4 hours after initiation of spinal anesthesia
measure: Intraoperative use of atropine
timeFrame: For 4 hours after initiation of spinal anesthesia
measure: Intraoperative use of supplemental fentanyl
timeFrame: For 4 hours after initiation of spinal anesthesia
measure: Intraoperative use of midazolam
timeFrame: For 4 hours after initiation of spinal anesthesia
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: DK
Study officials:
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Samah Elkenany, MD
role: PRINCIPAL_INVESTIGATOR
References: