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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-12-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly allocated to one of two groups each including 50 patients; the group received either intraarticular dexametomidine or neostigmine .

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

, Patients were randomly allocated (using random table assignment) into two groups to receive one of the following intra-articular solutions (prepared by an individual not involved in the study) which were injected into the knee joint through the cannular sheath after withdrawal of camera, by the orthopaedic surgeon (who was also unaware of the nature of the study drugs) before the arthroscope removed.

Study Groups

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dexmedetomidine (D group)

intraarticular administration of dexmedetomidine at the end of surgery

Group Type ACTIVE_COMPARATOR

dexamedetomidine

Intervention Type DRUG

intraarticular injection of 1µg/kg dexametomidine +18ml 0.25%bubivacaine in a total volume of 20 ml.

neostigmine (N group)

intraarticular administration of neostigmine at the end of surgery.

Group Type ACTIVE_COMPARATOR

neostigmine

Intervention Type DRUG

intraarticular injection of 0.5mg/dose neostigmine +18ml 0.25%bubivacaine in a total volume of 20 ml.

Interventions

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dexamedetomidine

intraarticular injection of 1µg/kg dexametomidine +18ml 0.25%bubivacaine in a total volume of 20 ml.

Intervention Type DRUG

neostigmine

intraarticular injection of 0.5mg/dose neostigmine +18ml 0.25%bubivacaine in a total volume of 20 ml.

Intervention Type DRUG

Other Intervention Names

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precedex dexamedetomidine Hcl injection prostigmine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No