A Phase 1/2 interventional study of Placebo drug ( normal saline ) and neostigmine (reversal agent) in Tachycardia, Hypertension and Hypoxia, sponsored by Ziauddin University. Completed at 1 site in Pakistan. Open to participants aged 16 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Ziauddin University · Phase 1/2, Interventional, and Treatment
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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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
189 studies on the registry are indexed under Tachycardia; 24 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 117 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Ziauddin University is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
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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)
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 )
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
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
Heart rate
To observe Heart rate, via pulse oximeter and ECG
Time frame: From the time of extubation till discharge from post anaesthesia care unit
Blood Pressure
to observe Blood Pressure via Sphygmomanometer
Time frame: From the time of extubation till discharge from post anaesthesia care unit
Respiratory Rate
to observe respiratory rate via capnometer
Time frame: From the time of extubation till discharge from post anaesthesia care unit
Oxygen Saturation
to observe oxygen saturation via pulse oximeter
Time frame: From the time of extubation till discharge from post anaesthesia care unit
Airway reflexes
to observe cough and gag reflex via Binary scale e.g Yes/No
Time frame: From the time of extubation till discharge from post anaesthesia care unit
Residual paralysis
to observe head lift for more than 5 secs and firm hand grip via Bonary scale e.g Yes/No
Time frame: From the time of extubation till discharge from post anaesthesia care unit
Plan to share: No
Ran from Mar 2025 to primary completion in Jun 2025, 2 months.
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Ziauddin University