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.

NCT07097441 | Completed Phase 1

• 1 other identifier: 9110824FAANE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Tachycardia; Hypertension; Hypoxia; Hyperventilation; Residual Paralysis, Post Anesthesia

Outcome Measures

Primary Outcomes (4)

• Heart rate

  To observe Heart rate, via pulse oximeter and ECG

  From the time of extubation till discharge from post anaesthesia care unit

• Blood Pressure

  to observe Blood Pressure via Sphygmomanometer

  From the time of extubation till discharge from post anaesthesia care unit

• Respiratory Rate

  to observe respiratory rate via capnometer

  From the time of extubation till discharge from post anaesthesia care unit

• Oxygen Saturation

  to observe oxygen saturation via pulse oximeter

  From the time of extubation till discharge from post anaesthesia care unit

Secondary Outcomes (2)

• Airway reflexes

  From the time of extubation till discharge from post anaesthesia care unit

• Residual paralysis

  From the time of extubation till discharge from post anaesthesia care unit

Study Arms (2)

Neostigmine group ( Group B )

ACTIVE COMPARATOR

This group will reeive neostigmine ( reversal agent ) at the end of surgery before extubation and then haemodynamic parameters will be observed

Drug: neostigmine (reversal agent)

normal saline group ( Group A )

EXPERIMENTAL

This group will receive normal saline ( no reversal ) at the end of surgery before extubation and then haemodynamic parameters will be observed

Drug: Placebo drug ( normal saline )

Interventions

Placebo drug ( normal saline ) DRUG

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

Also known as: Group A

normal saline group ( Group A )

neostigmine (reversal agent) DRUG

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

Also known as: Group B

Neostigmine group ( Group B )

Eligibility Criteria

• Age: 16 Years - 70 Years
• Gender Eligibility Details: Male and female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• American society of anaesthesiology class 3 and above
• Any previous reaction to atracurium
• Active asthma
• Severe pulmonary cardiac kindney and liver disease

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin university

Karachi, Sindh, Pakistan

Location

Related Publications (20)

• 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.

  PMID: 9366929 RESULT

• 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 RESULT

• 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 RESULT

• Bartkowski RR. Incomplete reversal of pancuronium neuromuscular blockade by neostigmine, pyridostigmine, and edrophonium. Anesth Analg. 1987 Jul;66(7):594-8.

  PMID: 3605668 RESULT

• 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.

  PMID: 1356374 RESULT

• 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.

  PMID: 10492412 RESULT

• 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 RESULT

• 13 .Pollard BJ. Neuromuscular blocking agents and reversal agents. Anaesthesia & intensive care medicine. 2005 Jun 1;6(6):189-92.

  RESULT

• 12. Nagelhout J, Plaus K. Neuromuscular blocking agents, reversal agents, and their monitoring. Nurse anesthesia. 2017 May 27:179-202.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Use of atracurium and its reversal by anaesthesiologists at a tertiary care hospital. (2013). International Research Journal of Pharmacy, 4(3), 178-181.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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/

  PMID: 29261883 RESULT

• 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.

  PMID: 6161627 RESULT

Related Links

• 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

MeSH Terms

Conditions

Tachycardia; Hypertension; Hypoxia; Hyperventilation; Delayed Emergence from Anesthesia

Interventions

Saline Solution; Neostigmine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Postoperative Complications

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Asma Abdus Salam, Consultant anaesthesiology

  Ziauddin university clifton

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident anaesthesiology R4

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 31, 2025
• Study Start: March 12, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)