A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group.
NCT ID: NCT06620614
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2022-10-01
2023-12-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
NONE
Study Groups
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Fractionated group arm
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.
0.5% Heavy Bupivacaine
There are two groups.
Bolus arm group
In this group ,participants are given Injection Heavy Bupivacaine 0.5% 2.5ml bolus at a rate of 0.2ml/hr
0.5% Heavy Bupivacaine
There are two groups.
Interventions
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0.5% Heavy Bupivacaine
There are two groups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologist's Physical Status: I and II.
Exclusion Criteria
* 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.
50 Years
MALE
No
Sponsors
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National Academy of Medical Sciences, Nepal
OTHER_GOV
Responsible Party
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Shushma K C
Doctor
Principal Investigators
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Pusparaj Poudel, MD
Role: STUDY_CHAIR
Bir Hospital
Locations
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National Academy of Medical Sciences, Bir Hospital
Kathmandu, , Nepal
Countries
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References
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Nash J. Benign prostatic hyperplasia: prevalence and diagnosis. GM Journal. 2010;40:321-4
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.
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.
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
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.
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
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
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.
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.
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.
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.
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.
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
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.
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.
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
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
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
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
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
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
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187/2079/80
Identifier Type: -
Identifier Source: org_study_id
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