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

Primary Purpose

Knee Injuries

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
dexamedetomidine
neostigmine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring knee arthroscopy, dexmedetomidine, neostigmine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut governorate

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexmedetomidine (D group)

neostigmine (N group)

Arm Description

intraarticular administration of dexmedetomidine at the end of surgery

intraarticular administration of neostigmine at the end of surgery.

Outcomes

Primary Outcome Measures

postoperative pain
visual analogue pain scale

Secondary Outcome Measures

nausea,vomiting
nausea and vomiting scales
sedation
Ramsay sedation score

Full Information

First Posted
July 7, 2017
Last Updated
January 10, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03212495
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
knee arthroscopy, dexmedetomidine, neostigmine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly allocated to one of two groups each including 50 patients; the group received either intraarticular dexametomidine or neostigmine .
Masking
ParticipantCare Provider
Masking Description
, 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.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine (D group)
Arm Type
Active Comparator
Arm Description
intraarticular administration of dexmedetomidine at the end of surgery
Arm Title
neostigmine (N group)
Arm Type
Active Comparator
Arm Description
intraarticular administration of neostigmine at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
dexamedetomidine
Other Intervention Name(s)
precedex, dexamedetomidine Hcl injection
Intervention Description
intraarticular injection of 1µg/kg dexametomidine +18ml 0.25%bubivacaine in a total volume of 20 ml.
Intervention Type
Drug
Intervention Name(s)
neostigmine
Other Intervention Name(s)
prostigmine
Intervention Description
intraarticular injection of 0.5mg/dose neostigmine +18ml 0.25%bubivacaine in a total volume of 20 ml.
Primary Outcome Measure Information:
Title
postoperative pain
Description
visual analogue pain scale
Time Frame
36 hours after the end of the surgery.
Secondary Outcome Measure Information:
Title
nausea,vomiting
Description
nausea and vomiting scales
Time Frame
36 hours after the end of the surgery.
Title
sedation
Description
Ramsay sedation score
Time Frame
36 hours after the end of the surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
18567675
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.
Results Reference
result
PubMed Identifier
16835255
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.
Results Reference
result
PubMed Identifier
15329580
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.
Results Reference
result

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

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