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

NCT ID: NCT05751304

Last Updated: 2023-03-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group D

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Group K

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Ketamine

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

Intervention Type DRUG

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ziad Ahmed Ali

A comparative study between intrathecal dexmedetomidine VS ketamine with intrathecal bupivacaine in orthopedic lower limb surgeries.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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zeyad A Ali, Resident

Role: CONTACT

01159596946

Ahmed E Abd Elrahman, Professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

Reference Type BACKGROUND
PMID: 22227789 (View on PubMed)

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

Reference Type BACKGROUND
PMID: 16698416 (View on PubMed)

Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.

Reference Type BACKGROUND
PMID: 11460814 (View on PubMed)

Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.

Reference Type BACKGROUND
PMID: 17578977 (View on PubMed)

Other Identifiers

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Soh-Med-23-02-09

Identifier Type: -

Identifier Source: org_study_id

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