Effect of the Use of Atracurium With or Without Reversal Agent on Haemodynamic Parameters During Extubation: a Randomized Controlled Trial
| Registry | NCT07097441 |
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| Status | Completed |
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| Phase | Phase 1 / Phase 2 |
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| Study type | Interventional; randomized, parallel, masking: triple, treatment |
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| Enrollment | 100 (Actual) |
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| Sponsor | Ziauddin University (Other) |
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| Conditions | Tachycardia, Hypertension, Hypoxia, Hyperventilation, Residual Paralysis, Post Anesthesia |
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| Interventions | Placebo drug ( normal saline ), neostigmine (reversal agent) (Drug) |
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| Dates | start 2025-03-12, primary completion 2025-06-04, completion 2025-06-04, first posted 2025-07-31, last updated 2025-07-31 |
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| Locations | 1 site in Pakistan |
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Related Papers Related Patents Related Grants Related Experts
All trials for Tachycardia All trials for Hypertension All trials of Placebo drug ( normal saline ) All trials of neostigmine (reversal agent)
-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
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+Detailed description
Objective : 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 , and secondary objective was to observe post operative residual paralysis respiratory depression and cough and gag reflex Study design : Controlled , randomised , and triple Blind trial . Place and duration of study: Dr Ziauddin Hospital Clifton Karachi , from March to June 2025.
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
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Neostigmine group ( Group B ) | Active comparator | Drug: neostigmine (reversal agent) | This group will reeive neostigmine ( reversal agent ) at the end of surgery before extubation and then haemodynamic parameters will be observed |
| normal saline group ( Group A ) | Experimental | Drug: Placebo drug ( normal saline ) | 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 ) (Drug), also known as Group A: 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) (Drug), also known as Group B: 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
+Outcome measures
Primary outcomes
- Heart rate [From the time of extubation till discharge from post anaesthesia care unit]: To observe Heart rate, via pulse oximeter and ECG
- Blood Pressure [From the time of extubation till discharge from post anaesthesia care unit]: to observe Blood Pressure via Sphygmomanometer
- Respiratory Rate [From the time of extubation till discharge from post anaesthesia care unit]: to observe respiratory rate via capnometer
- Oxygen Saturation [From the time of extubation till discharge from post anaesthesia care unit]: to observe oxygen saturation via pulse oximeter
Secondary outcomes
- Airway reflexes [From the time of extubation till discharge from post anaesthesia care unit]: to observe cough and gag reflex via Binary scale e.g Yes/No
- Residual paralysis [From the time of extubation till discharge from post anaesthesia care unit]: to observe head lift for more than 5 secs and firm hand grip via Bonary scale e.g Yes/No
+Eligibility
Sex: All, ages: 16 Years to 70 Years, accepts healthy volunteers
Inclusion Criteria:
* American society of anaesthesiology class 1 and 2
* Surgeries lasting for 60 mins
* .Surgeries requiring general anaesthesia and tracheal intubation and single intubation dose of atracurium
Exclusion Criteria:
* American society of anaesthesiology class 3 and above
* Any previous reaction to atracurium
* Active asthma
* Severe pulmonary cardiac kindney and liver disease
+Locations (1)
| Facility | City | Country | Status |
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| Ziauddin university | Karachi, Sindh | Pakistan | |
+Publications
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- Results publication: 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. PMID 17893459
- Results publication: 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. PMID 10793602
- Results publication: Bartkowski RR. Incomplete reversal of pancuronium neuromuscular blockade by neostigmine, pyridostigmine, and edrophonium. Anesth Analg. 1987 Jul;66(7):594-8. PMID 3605668
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- Results publication: 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. PMID 9797517
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- Results publication: 12. Nagelhout J, Plaus K. Neuromuscular blocking agents, reversal agents, and their monitoring. Nurse anesthesia. 2017 May 27:179-202.
- Results publication: 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. PMID 23372884
- Results publication: 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. PMID 20576632
- Results publication: 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. PMID 9793671
- Results publication: Use of atracurium and its reversal by anaesthesiologists at a tertiary care hospital. (2013). International Research Journal of Pharmacy, 4(3), 178-181.
- Results publication: 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. PMID 34667360
- Results publication: 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. PMID 22091288
- Results publication: 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. PMID 30573962
- Results publication: 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. PMID 12717123
- Results publication: 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. PMID 37139057
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+Investigators