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Completed

NCT Number: NCT07097441

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.

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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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: 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

Other names: Group B

Primary outcomes

  1. Heart rate

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

    To observe Heart rate, via pulse oximeter and ECG

  2. Blood Pressure

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

    to observe Blood Pressure via Sphygmomanometer

  3. Respiratory Rate

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

    to observe respiratory rate via capnometer

  4. Oxygen Saturation

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

    to observe oxygen saturation via pulse oximeter

Secondary outcomes

  1. Airway reflexes

    Time frame: 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

  2. Residual paralysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

Effect of the Use of Atracurium With or Without Reversal Agent on Haemodynamic Parameters During Extubation: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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