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NCT Number: NCT06620614

A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group.

The goal of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing Transurethral Resection of Prostate(TURP) surgery under Subarachnoid block(SAB).

Seventy-two patients aged 50 years and above belonging to American Physical status I and II are divided into two study group.

Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.

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Key information

Conditions

Prostatic Hyperplasia, Benign Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

National Academy of Medical Sciences, Bir Hospital

Kathmandu, +977, Nepal

About this study

The aim of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing TURP surgery under SAB.

Seventy-two patients aged 50 years and above belonging to American Physical status I and II undergoing transurethral resection of prostate for benign enlargement of prostate under subarachnoid block are enrolled and are divided into two groups having 36 patients in each.

Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.

Intraoperative mean arterial pressure (MAP), heart rate, onset of sensory and motor block, duration of sensory and motor block, and total intraoperative consumption of vasopressor are observed and compared between the groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 50 years and above patients undergoing TURP surgery under SAB
  • American Society of Anesthesiologist's Physical Status: I and II.

Exclusion criteria

  • Patients with history of uncontrolled hypertension.
  • Patients with previous history of cerebrovascular accidents.
  • Patients with history of spinal deformity.
  • Patients with known allergy to local anesthetics.
  • Patient with Infection at site of injection.
  • Patient with history of coagulopathy.

Treatment and study plan

0.5% Heavy Bupivacaine

Combination Product

There are two groups.

Other names: 26 G Quincke's needle

Primary outcomes

  1. Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block

    Time frame: Throughout study completion,an average of 3 months

    Hypotension was defined when mean arterial pressure (MAP) decreased ≤20% from baseline.

  2. Comparision of heart rate in both participants with subarachnoid block

    Time frame: Throughout study completion,an average of 3 months

    Bradycardia was defined when heart rate is less than 60 beats per minute.

  3. Comparision of total consumption of vasopressors used during intraoperative period between the groups.

    Time frame: Throughout study completion,an average of 3 months

    Injection Mephentermine 6mg iv was given for hypotension

Secondary outcomes

  1. Comparision of time for onset of sensory between the groups.

    Time frame: Throughout study completion,an average of 3 months.

    Sensory block was assessed by loss of sensation to pinprick with blunted tip needle bilaterally in the dermatomal levels. It was tested every 3 min until achievement of maximum sensory block i.e. till T10 level

  2. Comparision of time for onset of motor block between the groups

    Time frame: Throughout study completion,an average of 3 months.

    Time required to reach Modified Bromage scale =3, where Bromage 0= no motor block ,Bromage 3= complete block of motor limb

  3. Comparision of the time of regression of sensory block between two groups.

    Time frame: Throughout study completion,an average of 3 months

    Loss of pinprick sensation every 30 minutes postoperatively until it reached the S2 segment

  4. Comparision of the time of regression motor block between two groups.

    Time frame: Throughout study completion,an average of 3 months.

    Assessed every 30 minutes postoperatively Time required to reach Modified Bromage scale =0, where Bromage 0= no motor block ,Bromage 3= complete block of motor limb.

  5. Comparision of adverse effects like nausea, vomiting and shivering between the groups

    Time frame: Throughout study completion,an average of 3 months.

    Side effects managed according to hospital protocol

Sponsors and collaborators

Lead sponsor

National Academy of Medical Sciences, Nepal

Other Gov

Registry information

Official study title

Comparative Study on Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine in Patients Undergoing Transurethral Resection of Prostate Surgery Under Subarachnoid Block.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 1, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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