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

Ain Shams University100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Post Spinal Shivering

Interventions

DexmedetomidineDRUG

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

FentanylDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: From injection to 3 hours postoperative

Secondary Outcomes

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. 1. = sleepy and arousable by verbal commands. 2. = sleepy and not arousable by verbal stimuli but arousable to a drowsy state by tactile stimuli. 3. = sleepy and not arousable to a drowsy state by tactile stimuli but can be aroused by painful stimuli

Time frame: 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

Time frame: From injection to 3 hours postoperative

Central Contacts

Rawan G Elsawah

CONTACT

+201151051144 emp14098@med.asu.edu.eg

Data from ClinicalTrials.gov

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