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.

Ziauddin University

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Drug: neostigmine (reversal agent); Drug: Placebo drug ( normal saline )

Study type: Interventional

Funder types: Other

Identifiers

NCT07097441

9110824FAANE

Details and patient eligibility

About

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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Full 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

Enrollment: 100 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Neostigmine group ( Group B )

Active Comparator group

Description:

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

Treatment:

Drug: neostigmine (reversal agent)

normal saline group ( Group A )

Experimental group

Description:

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

Treatment:

Drug: Placebo drug ( normal saline )