Sugammadex and Time to Extubation in Ophthalmic Surgery

Comparison of Sugammadex and Neostigmine for Time to Extubation in Adult Patients Undergoing Routine Ophthalmic Surgery Under General Anesthesia

This study is to invastigate if patients treated with sugammadex compared to neostigmine/atropine would be extubate faster upon emergence of anesthesia.

Study Overview

• Status: Completed
• Conditions: Sugammadex; Neostigmine; General Anesthesia Using Endotracheal Intubation; Extubation Readiness; Ophthalmologic Surgical Procedure
• Intervention / Treatment: Drug: sugammadex; Drug: Neostigmine + Atropine

Detailed Description

This is a retrospective case-control study including patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded. Patient characteristics, including age, gender, ASA classification, weight, and height, were collected. Anesthesia-related medications were recorded. The time points of anesthesia induction, start and end of surgery, reversal agent administration, and tracheal extubation were documented.

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404327
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study included patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded.

Description

Inclusion Criteria:

aged 18 years or older ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022 received rocuronium as the sole neuromuscular blocking agent maintained with sevoflurane or desflurane and intravenous fentanyl

Exclusion Criteria:

emergency surgery combined surgeries with other specialties

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sugammadex; those who use sugammadex for reversal of neuromuscular blockade	Drug: sugammadex; sugammadex used for neuromuscular reversal
neostigmine; those who use neostigmine/atroping for reversal of neuromuscular blockade	Drug: Neostigmine + Atropine; Neostigmine and Atropine used for neuromuscular reversal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From reversal to extubation	Time From reversal to extubation	Time From reversal to extubation
Time From the end of surgery to reversal	Time From the end of surgery to reversal	Time From the end of surgery to reversal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From induction to the end of surgery	Time From induction to the end of surgery	Time From induction to the end of surgery

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Yi-Ying Chiang, MD, China Medical Univerity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; sugammadex; ophthalmologic surgical procedures
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Cholinesterase Inhibitors; Mydriatics; Parasympathomimetics; Atropine; Neostigmine
• Other Study ID Numbers: CMUH112-REC3-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No