Optimal Single Dose Intrathecal Dexmedetomidine for Postoperative Analgesia

NCT02660658 | Unknown DMC

• 1 other identifier: R ∕ 16.01.15
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Surgery

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  The duration of analgesia, defined as the time from administering of intrathecal study solution (T0) to the time for the first rescue analgesic request

  For 13 hours after surgery

Secondary Outcomes (13)

• Postoperative pain score

  For 24 hours after surgery

• Onset of sensory blockade

  For 1 hour after initiaion of spinal anesthesia

• Onset of motor blockade

  For 2 hours after initiation of spinal anesthesia

• Highest dermatome level of sensory blockade

  For 4 hours after initiation of spinal anesthesia

• Time to motor regression

  For 6 hours after initiation of spinal anesthesia

Study Arms (1)

Intrathecal dexmedetomidine

OTHER

Up-down sequential allocation 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

Drug: Intrathecal dexmedetomidine

Interventions

Intrathecal dexmedetomidine DRUG

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

Intrathecal dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, DK, 050, Egypt

RECRUITING

Study Officials

• Samah Elkenany, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samah Elkenany, MD

CONTACT

00201002262557; sk_20022000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2016
• First Posted: January 21, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

EG (1)