Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study)

Phase 2

Completed

• Conditions: Knee Injuries
• Interventions: Drug: dexamedetomidine; Drug: neostigmine

• Registration Number: NCT03212495
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2017-08-01
• Primary Completion: 2017-11-01
• Study Completion: 2017-12-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine (D group)	dexamedetomidine	intraarticular administration of dexmedetomidine at the end of surgery
neostigmine (N group)	neostigmine	intraarticular administration of neostigmine at the end of surgery.

Primary Outcome Measures

Name	Time	Method
postoperative pain	36 hours after the end of the surgery.	visual analogue pain scale

Secondary Outcome Measures

Name	Time	Method
nausea,vomiting	36 hours after the end of the surgery.	nausea and vomiting scales
sedation	36 hours after the end of the surgery.	Ramsay sedation score

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt