Dexmedetomidine and Fentanyl As Adjuvants to Hyperbaric Bupivacaine for the Prevention of Post-spinal Shivering in Hip Arthroplasty Surgeries

NCT06834841 | Recruiting DMC

• 1 other identifier: FMASU MS147/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the efficacy of intrathecal dexmedetomidine versus intrathecal fentanyl when added to hyperbaric bupivacaine in the prevention of post-spinal shivering in patients undergoing hip arthroplasty surgeries and to observe their effects as regards to sedation and intensity of the block.

Conditions

Post Spinal Shivering

Outcome Measures

Primary Outcomes (1)

• Post spinal shivering

  Post spinal anaesthesia shivering will be graded by a blinded observer during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan, 1994 and Tsai and Chu, 2001: 0 = no shivering, 1. = piloerection or peripheral vasoconstriction but no visible shivering, 2. = muscular activity in only one muscle group, 3. = muscular activity in more than one muscle group but not generalized shivering, 4. = shivering involving the whole body. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring. Positive shivering or lower grade shivering will be treated with an IV bolus of pethidine (0.5 mg/kg)

  From injection to 3 hours postoperative

Secondary Outcomes (2)

• Sedation

  From injection to 3 hours postoperative

• Intensity of the block

  From injection to 3 hours postoperative

Study Arms (2)

Group D

ACTIVE COMPARATOR

For group D, the preservative-free dexmedetomidine 100 μg/ml will be loaded into a 100-unit insulin syringe (1 μg/unit) and 5 units will be added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine

Drug: Dexmedetomidine

Group F

ACTIVE COMPARATOR

For group F, fentanyl 25 mcg will be given intrathecally added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine.

Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

the preservative-free dexmedetomidine 100 μg/ml will be loaded into a 100-unit insulin syringe (1 μg/unit) and 5 units will be added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine

Also known as: Precedex

Group D

Fentanyl DRUG

Fentanyl (Fentanyl Hameln® 0.1mg/2ml) 25 mcg will be given intrathecally added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine

Group F

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I, ASA II or ASA III patients scheduled for hip arthroplasty surgeries under spinal anaesthesia.
• Age \> 20 years.

You may not qualify if:

• Patient refusal
• Patients with known neurologic and psychiatric illness.
• Contraindications for spinal anaesthesia as bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia.
• Height \<150 cm.
• Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
• Allergy to any of the drugs used in the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Central Study Contacts

Rawan G Elsawah

CONTACT

+201151051144; emp14098@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: April 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: February 10, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)