drugset / Trial / NCT06620614
A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group.
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-10-01
- Primary completion
- 2022-12-01
- Completion
- 2023-12-01
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 0.5 % | Intrathecal |
| Subject | Bupivacaine | Other / unclassified | 2.5 ml | Intrathecal |