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Impact of dividing the dose of sugammadex on reducing emergence cough

Impact of dividing the dose of sugammadex on reducing emergence cough - A prospective, randomized, double-blinded study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088139
Enrollment
64
Registered
2025-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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: Sugammadex: 2 mg/kg given as divided dose of 1 mg/kg intravenous over 10 seconds before extubation and remaining 1 mg/kg intravenous over 10 seconds immediately after extubation Control

Sponsors

Fortis Hospitals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) physical status 1 3 2. Body mass index (BMI) less than 35kg/m2 3. Scheduled to undergo elective surgery under general anaesthesia with endotracheal intubation

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Past history of allergy 3. History of neuromuscular disease, coagulopathy 4. Patients with severe hepatic or renal impairment 5. Haemodynamically unstable patients 6. Patients who are planned to remain intubated and mechanically ventilated or tracheostomized postoperatively 7. Pregnant or lactating women 8. Patients with active cough or history of smoking 9. History of asthma or chronic obstructive pulmonary disease 10. Difficult intubation requiring more than 3 attempts

Design outcomes

Primary

MeasureTime frame
To measure and compare the incidence and severity of emergence cough between two groups of patients: 1. One group (A) receiving the total dose of sugammadex (2 mg/kg) intravenous over 10 seconds prior to extubation, and 2. The other group (B) receiving half of the total 2 mg/kg dose (1 mg/kg intravenous over 10 seconds) before extubation, and the remaining half (1 mg/kg intravenous over 10 seconds) immediately after extubation.Timepoint: 1. Emergence time (time period from discontinuation of all anaesthetic agents to administration of intravenous reversal agent sugammadex) 2. Extubation time (time period from intravenous administration of reversal agent sugammadex to the time at which tracheal extubation is performed) 3. 1 minute after extubation 4. 5 minutes after extubation 5. 60 minutes in the Post Anaesthesia Care Unit (PACU).

Secondary

MeasureTime frame
To measure & compare the incidence of post-extubation desaturation (oxygen saturation less than 90% on facemask) between the two groupsTimepoint: 1. 1 minute after extubation 2. 5 minutes after extubation;To measure & compare post-extubation sedation levels graded with Ramsay Sedation Score (RSS).Timepoint: 1. 1 minute after extubation 2. 5 minutes after extubation ;Incidence of severe delayed post-operative coughTimepoint: 60 minutes in the Post Anaesthesia Care Unit (PACU);Incidence of post-operative sore throatTimepoint: 60 minutes in the Post Anaesthesia Care Unit (PACU)

Countries

India

Contacts

Public ContactDr Amruta Kulkarni

Fortis Hospitals Limited

vijay.drvijays@gmail.com9821076279

Outcome results

None listed

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