Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine

Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine on Hemodynamic Parameters in Patients Undergoing Transurethral Resection of the Prostate

Patients will be enrolled in one of the two groups using a computer-generated random number table: Group I will receive 1.5 ml of 0.5% hyperbaric bupivacaine (7.5 mg). Group II will receive 1.2 mL of 0.5% hyperbaric bupivacaine (6 mg) along with 0.3 mL (3 μg )of dexmedetomidine (total 1.5 mL).

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Bupivacain 0.5%; Drug: Dexmedetomidine Hydrochloride

Detailed Description

After approval of the synopsis and permission from the hospital ethics committee, all patients meeting the inclusion criteria will be included in the study. Patients will be instructed not to consume solid food after midnight before surgery and to take clear liquids up to 2 hours before surgery. Using a computer-generated random number table, patients will be enrolled in one of the two groups: Group I will receive 1.5 ml of 0.5% hyperbaric bupivacaine (7.5 mg). Group II will receive 1.2 mL of 0.5% hyperbaric bupivacaine (6 mg) along with 0.3 mL (5 μg )of dexmedetomidine (total of 1.5 mL). They will be randomly allocated into two groups using the sealed envelope technique by a person blinded to the procedure. The study medication will be prepared by an anaesthesiologist not involved in the study and another anaesthesiologist performing the spinal block will record the intraoperative and postoperative data. On arrival at the Operating Room (OR) monitors like a non-invasive blood pressure monitor (NIBP), peripheral oxygen saturation monitor (SpO2), and electrocardiography monitor (ECG) having lead II will be attached. All the baseline values of blood pressure (SBP, DBP, and MAP), heart rate and rhythm, and SPO2 will be observed and recorded. An intravenous (IV) line will be established with an 18-gauge cannula. The study drug solutions will look identical. For Group I, 7.5 mg(1.5 mL) of 0.5% hyperbaric bupivacaine hydrochloride will be drawn in a 3 mL BD syringe. For Group II, 6mg (1.3 mL) of 0.5% hyperbaric bupivacaine hydrochloride will be drawn in a 3 mL BD syringe. By using an insulin syringe, 0.3 mL (3 μg) of Dexmedetomidine (preservative free) 100 μg/mL will be added to the 6 mg (1.3 mL) of hyperbaric bupivacaine under complete aseptic conditions to bring the total volume to 1.5 mL. The total volume of drug solutions will be 1.5 mL in each group.

Local infiltration of the skin with 2mL of 2% lidocaine will be done to decrease the discomfort caused by the spinal needle. A spinal puncture will be performed at L3-L4 or L4-L5 with a midline approach using a 25-gauge Quincke needle in the sitting position. After verification of clear and free flow of cerebrospinal fluid, the drug will be administered and the patients will be placed in the supine position Vitals will be monitored Heart Rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), respiratory rate (RR), oxygen saturation (SpO2) for every 5 minutes till the end of surgery. If mean arterial pressure (MAP) decreases below 65 mmHg or the Heart rate falls below 65 beats per minute then intravenous vasopressors will be given. The sensory block levels will be checked on the bilateral mid-clavicular line with a pin prick with a blunt needle every 2 min from the time of drug injection until the sensory level achieves up to T10 level.

In contrast, the motor block will be assessed using the modified Bromage scale. The surgeon will be asked to start the surgery when the sensory block has reached the T10 level. After completion of the surgery, the patient will be shifted to the PACU and monitored for 3 hours with continuous ECG monitoring and intermittent non-invasive blood pressure monitoring at 5-minute intervals. All untoward events like shivering, nausea vomiting, sedation, and respiratory depression will be monitored and recorded in the operating room as well as in the recovery room.

All data will be recorded on Performa attached as Annex A after the consultant anesthetist confirms.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Syed Muhammad Abbas

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• ASA I to ASA II
• Age 50 to 80 years old
• Height between 155cm and 175 cm

Exclusion Criteria:

• History of spine surgery or the presence of an infectious focus on the back
• Patient's refusal to undergo a spinal anaesthesia
• Hypersensitivity to bupivacaine or dexmedetomidine
• Patients taking drugs of abuse or narcotic analgesics
• Diabetic neuropathy
• History of bleeding disorders
• Oral/intravenous anticoagulant therapy
• History of arrhythmias or labile hypertension
• Unco-operative patients
• Hearing defect
• ASA III and IV
• Central or peripheral nervous system disorders
• Severe hypovolemia

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BUPIPURE; Hyperbaric Bupivacaine 0.5% (1.5 ml/7.5 mg) to be given intrathecally Total volume 1.5 mL	Drug: Bupivacain 0.5%; Bupivacaine hydrochloride was given without any adjuvant; Other Names: Pure Bupivacain 0.5%
Experimental: BUPI-DEX; Hyperbaric Bupivacaine 0.5% (1.2 ml/6 mg)+Dexmedetomidine (0.3 mL) 3 microgram intrathecally. Total volume 1.5 mL	Drug: Bupivacain 0.5%; Bupivacaine hydrochloride was given without any adjuvant; Other Names: Pure Bupivacain 0.5%; Drug: Dexmedetomidine Hydrochloride; Use of Dexmedetomidine Hydrochloride 5 micrograms (1 mL) as an adjuvant with bupivacaine hydrochloride; Other Names: Dexmedetomidine 5 microgram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height of sensory block	Dermatome level having absence of cold sensation	0 to 4 hours
Motor block	According to Bromage scores Grade Criteria I Free movement of legs and feet II Just able to flex knees with free movement of feet III Unable to flex knees, but with free movement of feet IV Unable to move legs or feet we need paralysis of both legs (Bromage score IV) for surgery	0 to 4 hours
Time for 2 segment regression of sensory block	Dermatome level having absence of cold sensation	0 to 4 hours
Heart rate	By anaesthesia ECG monitor	0 to 4 hours
Mean Blood pressure	Non invasive blood pressure monitoring devise	0 to 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shivering	Bedside Shivering Assessment Score (BSAS) grade 0, if there is no shivering grade 1 if there is no muscle contraction but mild fasciculation of face or neck or peripheral vasoconstriction but no visible shivering, grade 2 if there is a visible muscular activity in only one muscle group, grade 3 if the muscular activity is in more than one muscle group but not generalized grade 4 if gross muscular activity involving the entire body. Grade 0 is better, increase in grade (0 -> 4) means worsening	0 to 4 hours

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation
• Investigators: Study Director: Ali A Lanewala, MD, PhD, Sindh Institute of Urology & Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: July 1, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: SAbbas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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