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NCT Number: NCT03212495

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

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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Key information

Conditions

Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut governorate

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dexamedetomidine

Drug

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

Other names: precedex, dexamedetomidine Hcl injection

Neostigmine

Drug

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

Other names: prostigmine

Primary outcomes

  1. postoperative pain

    Time frame: 36 hours after the end of the surgery.

    visual analogue pain scale

Secondary outcomes

  1. nausea,vomiting

    Time frame: 36 hours after the end of the surgery.

    nausea and vomiting scales

  2. sedation

    Time frame: 36 hours after the end of the surgery.

    Ramsay sedation score

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparison Between Intra-articular Dexmedetomidine and Neostigmine as Adjuvant Analgesics After Knee Arthroscopy

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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