Hypertension, Hyperventilation, Hypoxia, Residual Paralysis, Post Anesthesia, Tachycardia
Conditions
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 .
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
Interventions
DRUGPlacebo 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
DRUGneostigmine (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
Sponsors
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Pakistan
Outcome results
None listed