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

NCT03212495 | Completed Phase 2

• 1 other identifier: dexmedetomidine vs neostigmine
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Injuries

Keywords

knee arthroscopy; dexmedetomidine; neostigmine

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  visual analogue pain scale

  36 hours after the end of the surgery.

Secondary Outcomes (2)

• nausea,vomiting

  36 hours after the end of the surgery.

• sedation

  36 hours after the end of the surgery.

Study Arms (2)

dexmedetomidine (D group)

ACTIVE COMPARATOR

intraarticular administration of dexmedetomidine at the end of surgery

Drug: dexamedetomidine

neostigmine (N group)

ACTIVE COMPARATOR

intraarticular administration of neostigmine at the end of surgery.

Drug: neostigmine

Interventions

dexamedetomidine DRUG

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

Also known as: precedex, dexamedetomidine Hcl injection

dexmedetomidine (D group)

neostigmine DRUG

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

Also known as: prostigmine

neostigmine (N group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

Related Publications (3)

• 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.

  PMID: 18567675 RESULT

• 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.

  PMID: 16835255 RESULT

• 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.

  PMID: 15329580 RESULT

MeSH Terms

Conditions

Knee Injuries

Interventions

Dexmedetomidine; Neostigmine

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: , 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: August 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

EG (1)