A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05751304
Collaborator
(none)
100
1
2
12
8.4

Study Details

Study Description

Brief Summary

Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group D

(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg dexametomidine.

Drug: Dexmedetomidine
(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg Dexametomidine.

Active Comparator: Group K

(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine.

Drug: Ketamine
(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine.

Outcome Measures

Primary Outcome Measures

  1. comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery [1 year]

    comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

-The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia .

Exclusion Criteria:
  • Patient refusal.

  • Drug abuse.

  • Patient with neurological, psychiatric or neuromuscular disease.

  • Chronic pain on medicine.

  • Known allergy to the study medications.

  • Patients e contraindications to intrathecal anesthesia .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ziad Ahmed Ali, A comparative study between intrathecal dexmedetomidine VS ketamine with intrathecal bupivacaine in orthopedic lower limb surgeries., Sohag University
ClinicalTrials.gov Identifier:
NCT05751304
Other Study ID Numbers:
  • Soh-Med-23-02-09
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2023