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.
NCT ID: NCT07097441
Last Updated: 2025-07-31
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/PHASE2
100 participants
INTERVENTIONAL
2025-03-12
2025-06-04
Brief Summary
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Detailed Description
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Methodology : This was a triple blind study . A total of 100 patients were randomly assigned by the CTU to two groups , the placebo group ( Group A ) and the neoglycopyrolate group (Group B) based on computer generated allocation. At the end of the surgery, patients in Group A were administered IV normal saline and Group B were administered neoglycopyrolate 50 mcg/kg . The primary outcome was to observe heart rate , blood pressure, oxygen saturation and respiratory rate after giving the drug , before extubation , at extubation and at 1mins, 5mins, 10mins, 20mins, and 2h thereafter, while the secondary outcome was to observe post operative airway reflexes and residual paralysis in the post anaesthesia care unit
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Neostigmine group ( Group B )
This group will reeive neostigmine ( reversal agent ) at the end of surgery before extubation and then haemodynamic parameters will be observed
neostigmine (reversal agent)
At the end of surgery patients will be given neostigmine ( reversal agenr ) , to observe Heart rate, blood pressure , respiratory rate and oxygen saturation on extubation and post operative airway reflexes and residual paralysis
normal saline group ( Group A )
This group will receive normal saline ( no reversal ) at the end of surgery before extubation and then haemodynamic parameters will be observed
Placebo drug ( normal saline )
At the end of surgery patients will be given placebo ( normal saline ) instead of neostigmine ( reversal agent of atracurium ) , to observe Heart rate, blood pressure , respiratory rate and oxygen saturation on extubation and post operative airway reflexes and residual paralysis
Interventions
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Placebo drug ( normal saline )
At the end of surgery patients will be given placebo ( normal saline ) instead of neostigmine ( reversal agent of atracurium ) , to observe Heart rate, blood pressure , respiratory rate and oxygen saturation on extubation and post operative airway reflexes and residual paralysis
neostigmine (reversal agent)
At the end of surgery patients will be given neostigmine ( reversal agenr ) , to observe Heart rate, blood pressure , respiratory rate and oxygen saturation on extubation and post operative airway reflexes and residual paralysis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgeries lasting for 60 mins
* .Surgeries requiring general anaesthesia and tracheal intubation and single intubation dose of atracurium
Exclusion Criteria
* Any previous reaction to atracurium
* Active asthma
* Severe pulmonary cardiac kindney and liver disease
16 Years
70 Years
ALL
Yes
Sponsors
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Ziauddin University
OTHER
Responsible Party
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Fariha Ahmed
Resident anaesthesiology R4
Principal Investigators
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Asma Abdus Salam, Consultant anaesthesiology
Role: STUDY_CHAIR
Ziauddin university clifton
Locations
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Ziauddin university
Karachi, Sindh, Pakistan
Countries
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References
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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.
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.
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.
Bartkowski RR. Incomplete reversal of pancuronium neuromuscular blockade by neostigmine, pyridostigmine, and edrophonium. Anesth Analg. 1987 Jul;66(7):594-8.
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.
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.
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.
13 .Pollard BJ. Neuromuscular blocking agents and reversal agents. Anaesthesia & intensive care medicine. 2005 Jun 1;6(6):189-92.
12. Nagelhout J, Plaus K. Neuromuscular blocking agents, reversal agents, and their monitoring. Nurse anesthesia. 2017 May 27:179-202.
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.
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.
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.
Use of atracurium and its reversal by anaesthesiologists at a tertiary care hospital. (2013). International Research Journal of Pharmacy, 4(3), 178-181.
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.
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.
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.
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.
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.
Neely GA, Sabir S, Kohli A. Neostigmine. 2025 Jan 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470596/
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.
Related Links
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A total of 31 patients were randomized to sugammadex, and 30 patients were randomized to neostigmine. Except for anesthesia time, there were no significant differences in any of the clinical characteristics between the two groups. The results demonstrate
orty patients were allocated into two equal groups. In Group E, at the end of surgery, extubation was performed and reversal was administered after extubation. In Group L, reversal was given and patients were extubated in the traditional way. Quality of
Two hundred and sixteen patients scheduled for elective surgery under general anaesthesia requiring tracheal intubation were included in the study. They received a single intubating dose of intravenous atracurium (0.5 mg/kg) to facilitate tracheal intuba
the pharmacological properties of atracurium are of sufficient interest to merit its evaluation as a neuromuscular blocking agent in anaesthetized man
Other Identifiers
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9110824FAANE
Identifier Type: -
Identifier Source: org_study_id