Clinical trial NCT03212495: Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study)
Official title: Comparison Between Intra-articular Dexmedetomidine and Neostigmine as Adjuvant Analgesics After Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Knee Injuries
Keywords: knee arthroscopy
dexmedetomidine
neostigmine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated to one of two groups each including 50 patients; the group received either intraarticular dexametomidine or neostigmine .
Primary purpose: TREATMENT

Brief summary: Knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis, meniscectomy or debridement. Arthroscopic surgery is associated with a variable degree of postoperative pain, which is caused by an irritation of free nerve endings of the synovial tissue, anterior fat pad, and joint capsule due to surgical excision and resection

Detailed description: Many studies were done using different intra-articular agents as local anesthetics, opioids, ketamine and alfa2- adrenergic agonists for prevention and treatment of pain after knee surgeries.

Dexmedetomidine is a potent and highly selective alfa2-adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, analgesic, anesthetic and sympatholytic effects. Intra-articular dexmedetomidine was used in several studies to enhance postoperative analgesia after knee arthroscopy with an increased time to first analgesic request and a decreased need for postoperative analgesia Neostigmine is an anticholinesterase and also has antinociceptive effects when administered intrathecally or peripherally.

Eligibility criteria: Inclusion Criteria:

* patients aged above 18 years
* scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia

Exclusion Criteria:

* Absolute or relative contraindications for intrathecal anaesthesia,
* Allergy for the studied drugs.
* Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,
* Patients receiving chronic pain treatment or hypertension treated with alfa methyldopa, clonidine or beta adrenergic blockers were excluded from the study.

Primary outcomes:
measure: postoperative pain
timeFrame: 36 hours after the end of the surgery.
Secondary outcomes:
measure: nausea,vomiting
timeFrame: 36 hours after the end of the surgery.
measure: sedation
timeFrame: 36 hours after the end of the surgery.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
References:
citation: Al-Metwalli RR, Mowafi HA, Ismail SA, Siddiqui AK, Al-Ghamdi AM, Shafi MA, El-Saleh AR. Effect of intra-articular dexmedetomidine on postoperative analgesia after arthroscopic knee surgery. Br J Anaesth. 2008 Sep;101(3):395-9. doi: 10.1093/bja/aen184. Epub 2008 Jun 20.
citation: Bondok RS, Abd El-Hady AM. Intra-articular magnesium is effective for postoperative analgesia in arthroscopic knee surgery. Br J Anaesth. 2006 Sep;97(3):389-92. doi: 10.1093/bja/ael176. Epub 2006 Jul 11.
citation: Ebert T, Maze M. Dexmedetomidine: another arrow for the clinician's quiver. Anesthesiology. 2004 Sep;101(3):568-70. doi: 10.1097/00000542-200409000-00003. No abstract available.