A study to compare the effect of two medications (Neostigmine and Sugammadex) on breathing, after facial surgery by using ultrasonography to measure the function of respiratory muscle.

Comparison of Effect of Neostigmine And Sugammadex On Post Operative Diaphragmatic Function assessed Ultrasonographically in Adult Patients Undergoing Oro-Maxillofacial Surgery: A Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068399

Enrollment

Registered

2024-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Comparing the effect of Neostigmine and Sugammadex on the recovery of diaphragmatic muscle strength in the post extubation period using ultrasonography. : Preoperative ultrasonography w

Eligibility

Inclusion criteria

Inclusion criteria: Adults (18-65 years) undergoing elective oro-maxillofacial surgeries under general anaesthesia, receiving neuromuscular blockade.

Exclusion criteria

Exclusion criteria: 1.Patients denying consent to participate in the study. 2.Patients with lung disease- COPD, ILD. 3.Any condition in which diaphragm cannot be assessed using ultrasonography. 4.Patients with diaphragmatic hernia, ascites, stroke, pregnancy 5.Patients with suspected neuromuscular disease/ phrenic nerve injury. 6.Patients who require postoperative mechanical ventilation. 7.Patients with any contraindications or known allergy to Neostigmine or Sugammadex.

Design outcomes

Primary

Measure	Time frame
Comparison of the change in diaphragmatic excursion at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade. Timepoint: At baseline and at TOFR more than 0.9	—

Secondary

Measure	Time frame
Any side effects of Neostigmine and Sugammadex. Timepoint: From TOFR 0.7 till 30 minutes after in PACU;Comparison of the change in diaphragmatic excursion at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.Timepoint: At baseline and after 30 minutes in PACU;Comparison of the change in diaphragmatic thickness fraction at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade. Timepoint: At baseline and after 30 minutes in PACU;Comparison of the change in diaphragmatic thickness fraction at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade. Timepoint: At baseline and at TOFR more than 0.9;Comparison of the change in internal oblique muscle thickness fraction at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.Timepoint: At baseline and after 30 minutes in PACU;Comparison of the change in internal oblique thickness fraction at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade. Timepoint: At baseline and at TOFR more than 0.9;Time taken to achieve a TOFR more than 0.9 after injecting Neostigmine and Sugammadex. Timepoint: From TOFR 0.7 to TOFR 0.9	—

Measure

Time frame

Any side effects of Neostigmine and Sugammadex. Timepoint: From TOFR 0.7 till 30 minutes after in PACU;Comparison of the change in diaphragmatic excursion at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.Timepoint: At baseline and after 30 minutes in PACU;Comparison of the change in diaphragmatic thickness fraction at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade. Timepoint: At baseline and after 30 minutes in PACU;Comparison of the change in diaphragmatic thickness fraction at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade. Timepoint: At baseline and at TOFR more than 0.9;Comparison of the change in internal oblique muscle thickness fraction at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.Timepoint: At baseline and after 30 minutes in PACU;Comparison of the change in internal oblique thickness fraction at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade. Timepoint: At baseline and at TOFR more than 0.9;Time taken to achieve a TOFR more than 0.9 after injecting Neostigmine and Sugammadex. Timepoint: From TOFR 0.7 to TOFR 0.9

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Countries

India

Contacts

Public ContactDr Amrita Priya Nair

All India Institute of Medical Sciences Jodhpur

swati_virgo83@yahoo.co.in07340033034

Outcome results

None listed

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