To Observe Haemodynamic Parameters Including, Heart Rate, Blood Pressure, Respiratory Rate , and Oxygen Saturation, With or Without Giving Reversal Agent on Extubation, in Patients Receiving Single Shot of Atracurium , and to Observe Post Operative Residual Paralysis and Airway Reflexes in PACU.
Summary
The goal of this clinical trial is to to observe the haemodynamic parameters including Heart Rate Blood pressure Respiratory rate and Oxygen Saturation with or without giving reversal agent on extubation in patients receiving atracurium on induction , it will also observe post operative residual paralysis respiratory depression and airway reflexes in the post anaesthesia care unit Researchers will compare neostigmine which is the reversal agent and the placebo drug by giving it at the end on surgery before extubation to observe haemodynamic parameters The main questions it aims to answer are Will participants have a stable haemodymaics if no reversal ( neostigmine ) is used during extubation Will it provide a safe extubation and no complications post operatively Participants will be given Either neostigmine or placebo drug at the end of surgery before extubation Will be obseved and monitored for two hours postoperatively in the post anaesthesia care unit Will be monitored for post operative complications like respiratory depression or residual paralysis .
Timeline
- Start
- 2025-03-12
- Primary completion
- 2025-06-04
- Completion
- 2025-06-04
Publications
- Results Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
- Results Eikermann M, Fassbender P, Malhotra A, Takahashi M, Kubo S, Jordan AS, Gautam S, White DP, Chamberlin NL. Unwarranted administration of acetylcholinesterase inhibitors can impair genioglossus and diaphragm muscle function. Anesthesiology. 2007 Oct;107(4):621-9. doi: 10.1097/01.anes.0000281928.88997.95.
- Results Baillard C, Gehan G, Reboul-Marty J, Larmignat P, Samama CM, Cupa M. Residual curarization in the recovery room after vecuronium. Br J Anaesth. 2000 Mar;84(3):394-5. doi: 10.1093/oxfordjournals.bja.a013445.
- Results Bartkowski RR. Incomplete reversal of pancuronium neuromuscular blockade by neostigmine, pyridostigmine, and edrophonium. Anesth Analg. 1987 Jul;66(7):594-8.
- Results Fragen RJ. Role of reversal agents. J Clin Anesth. 1992 Sep-Oct;4(5 Suppl 1):9S-15S. doi: 10.1016/0952-8180(92)90012-p. No abstract available.
- Results Kirkegaard-Nielsen H, Severinsen IK, Pedersen HS, Lindholm P. Factors predicting atracurium reversal time. Acta Anaesthesiol Scand. 1999 Sep;43(8):834-41. doi: 10.1034/j.1399-6576.1999.430809.x.
- Results Carroll MT, Mirakhur RK, Lowry D, Glover P, Kerr CJ. A comparison of the neuromuscular blocking effects and reversibility of cisatracurium and atracurium. Anaesthesia. 1998 Aug;53(8):744-8. doi: 10.1046/j.1365-2044.1998.00530.x.
- Results 13 .Pollard BJ. Neuromuscular blocking agents and reversal agents. Anaesthesia & intensive care medicine. 2005 Jun 1;6(6):189-92.
- Results 12. Nagelhout J, Plaus K. Neuromuscular blocking agents, reversal agents, and their monitoring. Nurse anesthesia. 2017 May 27:179-202.
- Results Lee H, Jeong S, Choi C, Jeong H, Lee S, Jeong S. Anesthesiologist's satisfaction using between cisatracurium and rocuronium for the intubation in the anesthesia induced by remifentanil and propofol. Korean J Anesthesiol. 2013 Jan;64(1):34-9. doi: 10.4097/kjae.2013.64.1.34. Epub 2013 Jan 21.
- Results Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24.
- Results Reich DL, Mulier J, Viby-Mogensen J, Konstadt SN, van Aken HK, Jensen FS, DePerio M, Buckley SG. Comparison of the cardiovascular effects of cisatracurium and vecuronium in patients with coronary artery disease. Can J Anaesth. 1998 Aug;45(8):794-7. doi: 10.1007/BF03012152.
- Results Use of atracurium and its reversal by anaesthesiologists at a tertiary care hospital. (2013). International Research Journal of Pharmacy, 4(3), 178-181.
- Results Babu KC, Rajan S, Sandhya SVK, Raj R, Paul J, Kumar L. Effectiveness and Safety of Extubation before Reversal of Neuromuscular Blockade versus Traditional Technique in Providing Smooth Extubation. Anesth Essays Res. 2021 Jan-Mar;15(1):133-137. doi: 10.4103/aer.aer_78_21. Epub 2021 Aug 30.
- Results Varposhti MR, Heidari SM, Safavi M, Honarmand A, Raeesi S. Postoperative residual block in postanesthesia care unit more than two hours after the administration of a single intubating dose of atracurium. J Res Med Sci. 2011 May;16(5):651-7.
- Results Luo J, Chen S, Min S, Peng L. Reevaluation and update on efficacy and safety of neostigmine for reversal of neuromuscular blockade. Ther Clin Risk Manag. 2018 Dec 10;14:2397-2406. doi: 10.2147/TCRM.S179420. eCollection 2018.
- Results Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.
- Results Tsai YH, Chen CY, Wong HF, Chou AH. Comparison of neostigmine and sugammadex for hemodynamic parameters in neurointerventional anesthesia. Front Neurol. 2023 Apr 17;14:1045847. doi: 10.3389/fneur.2023.1045847. eCollection 2023.
- Results Neely GA, Sabir S, Kohli A. Neostigmine. 2025 Jan 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470596/
- Results Hughes R, Chapple DJ. The pharmacology of atracurium: a new competitive neuromuscular blocking agent. Br J Anaesth. 1981 Jan;53(1):31-44. doi: 10.1093/bja/53.1.31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Neostigmine | Other / unclassified | — | — |