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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Spinal Shivering
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Fentanyl

Detailed Description

Preoperative settings:

All patients fulfilling the inclusion criteria who are undergoing hip arthroplasty surgeries and receiving spinal anaesthesia will be randomised into 2 equal groups, namely group D (Dexmedetomidine group) and group F (Fentanyl group).

Routine pre-operative assessment will be done for all patients including routine history taking, clinical examination, and laboratory investigations (complete blood picture, kidney function tests, liver function tests, prothrombin time, partial thromboplastin time).

An informed written consent will be taken from every patient just before the surgery.

Intraoperative and postoperative settings:

On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. All the patients will be preloaded with 10 ml/kg of Ringer's solution through peripheral intravenous cannula and monitored with five leads electrocardiography, pulse oximetry, and non-invasive blood pressure (NIBP) (which records systolic, diastolic, and mean blood pressure every 5 min intraoperatively and every 15 min in the recovery room, heart rate was recorded in the same intervals).

Under complete aseptic technique, local anaesthetic in the form of 3 ml of lidocaine 2% will be given at the site of spinal injection. Subarachnoid block will be administered in the sitting position midline approach with 25 gauge (Quincke needle) at L3-L4/L4-L5 space.

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.

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

Patients will be immediately placed in the supine position after completing the spinal block.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rawan G Elsawah; Phone Number: +201151051144; Email: emp14098@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University
    • Contact: Rawan G Elsawah; Phone Number: +201151051144; Email: emp14098@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASA I, ASA II or ASA III patients scheduled for hip arthroplasty surgeries under spinal anaesthesia.

Age > 20 years.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group D; 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; 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; Other Names: Precedex
Active Comparator: Group F; For group F, fentanyl 25 mcg will be given intrathecally added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine.	Drug: Fentanyl; Fentanyl (Fentanyl Hameln® 0.1mg/2ml) 25 mcg will be given intrathecally added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,; = piloerection or peripheral vasoconstriction but no visible shivering,; = muscular activity in only one muscle group,; = muscular activity in more than one muscle group but not generalized shivering,; = 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation	Patients will be assessed for sedation using a 4-point sedation score as following: 0 = Alert or drowsy but easily aroused to an alert state by verbal commands alone.; = sleepy and arousable by verbal commands.; = sleepy and not arousable by verbal stimuli but arousable to a drowsy state by tactile stimuli.; = sleepy and not arousable to a drowsy state by tactile stimuli but can be aroused by painful stimuli	From injection to 3 hours postoperative
Intensity of the block	Peak sensory level and time to reach this level, time to the first two segment regression, and time to first analgesic rescue will be recorded	From injection to 3 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Estimated): February 10, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine; Fentanyl
• Other Study ID Numbers: FMASU MS147/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be shared once the study is completed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No