Use of Sugammadex or Neostigmine as reversal agent for Neuromuscular Blockade in obese patients.

The Efficacy and Safety of Sugammadex and Neostigmine for reversing Rocuronium induced neuromuscular blockade in Obese patients - Nill

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063037

Enrollment

Registered

2024-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E660- Obesity due to excess calories

Interventions

Intervention1: Inj Sugammadex 2mg/kg iv for reversal of Rocuronium induced Neuromuscular blockade at end of surgery.: At end of surgery,patients will receive a dose of sugammadex (2 mg/kg), as an i.v

Eligibility

Inclusion criteria

Inclusion criteria: 1) Obese patients 2) Obese patients undergoing general anesthesia requiring muscle relaxants.

Exclusion criteria

Exclusion criteria: 1)Difficult Airway 2) Neuromuscular disorder that could impair neuromuscular blockade. 3) Significant renal or hepatic dysfunction. 4) Family history of malignant hyperthermia. 5) Patients receiving medication (for example: magnesium, anticonvulsants, aminoglycosides) expected to interfere with the muscle relaxant. 6) Patients requiring post -operative ventilator support. 7) Patients already intubated or tracheostomized. 8) Patient refusal. 9) Pregnant or lactating women. 10) Any allergy to study drugs

Design outcomes

Primary

Measure	Time frame
To compare efficacy of Sugammadex and Neostigmine in reversing neuromuscular blockade in terms of duration of the complete recovery from neuromuscular blocking agents (TOF 0.9)and time to extubation.Timepoint: At end of surgey, patients will receive either a dose of sugammadex (2 mg/kg), as an i.v. bolus (within 10 s) into a fast-running saline infusion or Inj Neostigmine 0.5mg/kg with glycopyrrolate(8mcg/kg) and time from drug administration and complete NMB reversal (TOF ratio = 0.9) and time to extubation will be noted.	—

Measure

Time frame

To compare efficacy of Sugammadex and Neostigmine in reversing neuromuscular blockade in terms of duration of the complete recovery from neuromuscular blocking agents (TOF 0.9)and time to extubation.Timepoint: At end of surgey, patients will receive either a dose of sugammadex (2 mg/kg), as an i.v. bolus (within 10 s) into a fast-running saline infusion or Inj Neostigmine 0.5mg/kg with glycopyrrolate(8mcg/kg) and time from drug administration and complete NMB reversal (TOF ratio = 0.9) and time to extubation will be noted.

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Secondary

Measure	Time frame
The secondary outcome will be incidence of postoperative curarization or pulmonary complications such as cough, breath holding, increased secretion, desaturation (SpO2=90), decreased breath frequency, pneumonia, reintubation, ICU admission, bradycardia, & hypotension seen within 24 hours of Inj Sugammadex or Inj Neostigmine administration.Timepoint: Any complications or side effects from the time of Inj Sugammadex or Inj Neostigmine Administration till 24hrs postoperatively.	—

Measure

Time frame

The secondary outcome will be incidence of postoperative curarization or pulmonary complications such as cough, breath holding, increased secretion, desaturation (SpO2=90), decreased breath frequency, pneumonia, reintubation, ICU admission, bradycardia, & hypotension seen within 24 hours of Inj Sugammadex or Inj Neostigmine administration.Timepoint: Any complications or side effects from the time of Inj Sugammadex or Inj Neostigmine Administration till 24hrs postoperatively.

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Countries

India

Contacts

Public ContactDr Sumedha Mehta

Smt Kashibai Navale Medical College and General Hospital

drsumedhamehta1@gmail.com09923091187

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026