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

NCT06620614 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 187/2079/80
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Hyperplasia, Benign

Keywords

Fractionated Dose; Heavy Bupivacaine; Spinal Anesthesia

Outcome Measures

Primary Outcomes (3)

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

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

  Throughout study completion,an average of 3 months

• Comparision of heart rate in both participants with subarachnoid block

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

  Throughout study completion,an average of 3 months

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

  Injection Mephentermine 6mg iv was given for hypotension

  Throughout study completion,an average of 3 months

Secondary Outcomes (5)

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

  Throughout study completion,an average of 3 months.

• Comparision of time for onset of motor block between the groups

  Throughout study completion,an average of 3 months.

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

  Throughout study completion,an average of 3 months

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

  Throughout study completion,an average of 3 months.

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

  Throughout study completion,an average of 3 months.

Study Arms (2)

Fractionated group arm

EXPERIMENTAL

In this group ,participants are given 1.6 ml of Injection Heavy Bupivacaine 0.5% initially followed by 0.9ml after 60 seconds at a rate of 0.2ml/hr.

Combination Product: 0.5% Heavy Bupivacaine

Bolus arm group

PLACEBO COMPARATOR

In this group ,participants are given Injection Heavy Bupivacaine 0.5% 2.5ml bolus at a rate of 0.2ml/hr

Combination Product: 0.5% Heavy Bupivacaine

Interventions

0.5% Heavy Bupivacaine COMBINATION_PRODUCT

There are two groups.

Also known as: 26 G Quincke's needle

Bolus arm group; Fractionated group arm

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: All male participants from 50 years and above
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Academy of Medical Sciences, Nepal: lead

Study Sites (1)

National Academy of Medical Sciences, Bir Hospital

Kathmandu, +977, Nepal

Location

Related Publications (20)

• Nash J. Benign prostatic hyperplasia: prevalence and diagnosis. GM Journal. 2010;40:321-4

  BACKGROUND

• Persu C, Georgescu D, Arabagiu I, Cauni V, Moldoveanu C, Geavlete P. TURP for BPH. How large is too large? J Med Life. 2010 Oct-Dec;3(4):376-80.

  PMID: 21254734 BACKGROUND

• Bhattacharyya S, Bisai S, Biswas H, Tiwary MK, Mallik S, Saha SM. Regional anesthesia in transurethral resection of prostate (TURP) surgery: A comparative study between saddle block and subarachnoid block. Saudi J Anaesth. 2015 Jul-Sep;9(3):268-71. doi: 10.4103/1658-354X.158497.

  PMID: 26240544 BACKGROUND

• Gandhi M, Kabir KK, Arora KK, Tiwari K. Comparative study between fractionated and single bolus dose of local anaesthetic in elective lower segment caeserean section. Indian J Clin Anaesth. 2019;6(3):386-90

  BACKGROUND

• Kararmaz A, Kaya S, Turhanoglu S, Ozyilmaz MA. Low-dose bupivacaine-fentanyl spinal anaesthesia for transurethral prostatectomy. Anaesthesia. 2003 Jun;58(6):526-30. doi: 10.1046/j.1365-2044.2003.03153.x.

  PMID: 12846615 BACKGROUND

• Beed M. Anaesthesia for gynaecological and genitourinary surgery. In: Aitkenhead A, Thompson J, Rowbotham D, Moppett I, editors. Smith and Aitkenhead's Textbook of Anaesthesia. 6 th edition. London: Churchill Livingstone/Elsevier; 2013. p. 568-77

  BACKGROUND

• Puri N, Talwar A. Comparative Study of Ephedrine and Mephertermine in Treatment of Hypotension in Patients Undergoing Elective Trans Urethral Resection Prostate (TURP). Journal of Bangladesh College of Physicians and Surgeons. 2010;28(1):10-6

  BACKGROUND

• Favarel-Garrigues JF, Sztark F, Petitjean ME, Thicoipe M, Lassie P, Dabadie P. Hemodynamic effects of spinal anesthesia in the elderly: single dose versus titration through a catheter. Anesth Analg. 1996 Feb;82(2):312-6. doi: 10.1097/00000539-199602000-00017.

  PMID: 8561333 BACKGROUND

• Nugroho AM, Sugiarto A, Chandra S, Lembahmanah L, Septica RI, Yuneva A. A Comparative Study of Fractionated Versus Single Dose Injection for Spinal Anesthesia During Cesarean Section in Patients with Pregnancy-Induced Hypertension. Anesth Pain Med. 2019 Feb 6;9(1):e85115. doi: 10.5812/aapm-85115. eCollection 2019 Feb.

  PMID: 30881909 BACKGROUND

• Norris MC. Neuraxial anaesthesia. In: Barash PG, Cullen BF, Stoelting RK, Cahalan MK, Stock MC, Ortega R, Sharar SM, Holt NF, editors. Clinical Anaesthesia. 8 thedition. New Delhi: Wolters Kluwer; 2017. p. 914-44.

  BACKGROUND

• Brull R, Macfarlane AJ, Chan VW. Spinal, epidural, and caudal anaesthesia. In: Miller RD, editor. Miller's anaesthesia. 8 th edition. Philadelphia: Elsevier Saunders;2015. p. 1684-720.

  BACKGROUND

• Badheka JP, Oza VP, Vyas A, Baria D, Nehra P, Babu T. Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section: A randomised, double-blind study. Indian J Anaesth. 2017 Jan;61(1):55-60. doi: 10.4103/0019-5049.198390.

  PMID: 28216705 BACKGROUND

• Ramasali M.V., Vankaylapatti S. D., Appagalla S, Kulkarni D. K., Pasupuleti S. A Prospective Randomised Double-Blind Comparative Study of Bolus versus Fractionated Dose Injection in Spinal Anaesthesia for Pregnant Women undergoing elective Caesarean Section. Indian J Anesth Anal 2018; 5(11):1840-45

  BACKGROUND

• Derakhshan P, Faiz SHR, Rahimzadeh P, Salehi R, Khaef G. A Comparison of the Effect of Fractionated and Bolus Dose Injection on Spinal Anesthesia for Lower Limb Surgery: A Randomized Clinical Trial. Anesth Pain Med. 2020 Aug 23;10(5):e102228. doi: 10.5812/aapm.102228. eCollection 2020 Oct.

  PMID: 34150559 BACKGROUND

• Kaniyil S, Priya PG, Nithinkumar MP, Sneha SR. Fractional spinal anaesthesia in high-risk elderly patients for orthopaedic surgery - Case series. Indian J Anaesth. 2023 Jul;67(7):651-654. doi: 10.4103/ija.ija_888_22. Epub 2023 Jul 14.

  PMID: 37601939 BACKGROUND

• Tiwari K, Masar R. Comparison Between Fractionated and Single Bolus Dose of Local Anaesthetic (Bupivacaine 0.5% Heavy) in Elective Lower Segment Caeserean Section. Int. J. Health Clin. Res. 2020; 3(6):36-42

  BACKGROUND

• Srivastava N, Ahluwalia P, Jheetay GS, Singh G. Bolus dose versus fractionated dose injection of hyperbaric bupivacaine in spinal anaesthesia among adult patients undergoing lower limb surgery: A prospective study. Indian J Clin Anaesth. 2020;7(2):238-44

  BACKGROUND

• Hossain MM, Biswas B, Mohanta PK, Hassan MM, Basu P, Islam F. Comparison between fractionated dose with bolus dose in Spinal Anaesthesia for haemodynamic stability and duration of analgesia in patients undergoing elective Lower Segment Caesarean Section (LSCS). Mediscope. 2020 Sep 29;7(2):95-102

  BACKGROUND

• Sowmya NL. Comparison of Fractionated versus Bolus Dose Injection of Drug in Spinal Anaesthesia for Lower Limb Surgeries. Int. J. Sci. Res. 2020;Vol 9

  BACKGROUND

• Mahbuba S, Chy MM, Naz S, Begum M, Jahan SS, Sheikh ZA. Comparison of sensory and motor block outcome of fractionated versus single bolus dose administration of hyperbaric bupivacaine in elective cesarean section. Medico Research Chronicles. 2021 ;8(4):317-24

  BACKGROUND

Related Links

• This study describes about prevalence of benign prostatic hyperlasia in elderly male.
• This article describes about TURP for Benign Prostatic Hyperplasia
• This article describes about comparision between saddle and subarachnoid block in TURP surgery.
• This article describes about Low-dose bupivacaine-fentanyl spinal anaesthesia for transurethral prostatectomy.
• This is academic book of anesthesia
• This study describes about comparison of Ephedrine and Mephertermine in Treatment of Hypotension in Patients Undergoing Elective Trans Urethral Resection Prostate (TURP).
• This study describes about Hemodynamic effects of spinal anesthesia in the elderly: single dose versus titration through a catheter.
• This study describes about comparision of fractionated versus single dose injection for spinal anesthesia during cesarean section in patients with pregnancy-induced hypertension
• This is academic book of anesthesia
• This is academic book of anesthesia
• This study compares between fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section:
• This study compares between Bolus versus Fractionated Dose Injection in Spinal Anaesthesia for Pregnant Women undergoing elective Caesarean Section
• This study compares between Fractionated and Bolus Dose Injection on Spinal Anesthesia for Lower Limb Surgery
• This study compares between Fractional spinal anaesthesia in high-risk elderly patients for orthopaedic surgery
• This study compares between Fractionated and Single Bolus Dose of Local Anaesthetic (Bupivacaine 0.5% Heavy) in Elective Lower Segment Caeserean Section
• This study compares between fractionated dose with bolus dose in Spinal Anaesthesia for haemodynamic stability and duration of analgesia in patients undergoing elective Lower Segment Caesarean Section
• This study compares between Fractionated versus Bolus Dose Injection of Drug in Spinal Anaesthesia for Lower Limb Surgeries
• This study compares between sensory and motor block outcome of fractionated versus single bolus dose administration of hyperbaric bupivacaine in elective cesarean section

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pusparaj Poudel, MD

  Bir Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: An approval from the Institutional Review Board (IRB), NAMS was taken prior to commencing the study. 72 Patients of ASA physical status I or II scheduled for Transurethral Resection of prostate under Sub-arachnoid block were enrolled in the study. . Patient's characteristics including name, gender, age, body weight, height and body mass index were recorded. Patients were kept nil per oral as per American society of anesthesiologist guidelines prior to surgery. Study pouplation were divided into two groups: * Bolus group * Fractionated group

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)