Optimal Single Dose Intrathecal Dexmedetomidine for Postoperative Analgesia

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02660658
• Date of registration: 16/01/2016
• Prospective Registration: No
• Primary sponsor: Mansoura University
• Public title: Optimal Single Dose Intrathecal Dexmedetomidine for Postoperative Analgesia
• Scientific title: Optimal Single-dose Intrathecal Dexmedetomidine for Postoperative Analgesia After Lower Limb Surgery
• Date of first enrolment: January 2016
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02660658
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Egypt

Contacts

• Name: Samah Elkenany, MD

• Name: Samah Elkenany, MD

• Name: Samah Elkenany, MD
• Affiliation: Lecturer of Anesthesia and Surgical Intensive Care

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lower Limb Surgery

Intervention(s)

Drug: Intrathecal dexmedetomidine

Primary Outcome(s)

Duration of analgesia [Time Frame: For 13 hours after surgery]

Secondary Outcome(s)

Intraoperative use of atropine [Time Frame: For 4 hours after initiation of spinal anesthesia]

Intraoperative use of supplemental fentanyl [Time Frame: For 4 hours after initiation of spinal anesthesia]

Onset of motor blockade [Time Frame: For 2 hours after initiation of spinal anesthesia]

Postoperative nausea and vomiting [Time Frame: For 24 hours after initiation of spinal anesthesia]

Highest dermatome level of sensory blockade [Time Frame: For 4 hours after initiation of spinal anesthesia]

Cumulative tramadol consumption [Time Frame: For 24 hours after surgery]

Intraoperative use of ephedrine [Time Frame: For 4 hours after initiation of spinal anesthesia]

Intraoperative bradycardia [Time Frame: For 4 hours after initiation of spinal anesthesia]

Intraoperative use of midazolam [Time Frame: For 4 hours after initiation of spinal anesthesia]

Time to motor regression [Time Frame: For 6 hours after initiation of spinal anesthesia]

Postoperative pain score [Time Frame: For 24 hours after surgery]

Sedation score [Time Frame: For 24 hours after initiation of spinal anesthesia]

Onset of sensory blockade [Time Frame: For 1 hour after initiaion of spinal anesthesia]

Secondary ID(s)

R / 16.01.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors