NCT06987357

Brief Summary

The aim of this study was to retrospectively investigate the effects of sugammadex or neostigmine, which are routinely used after the completion of surgery to antagonize (reverse) neuromuscular blockade in adult patients undergoing cranial surgery under general anesthesia, on early extubation in the operating room, intensive care unit admission and length of stay, length of hospital stay, and hospital costs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 9, 2025

Last Update Submit

May 15, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • The amount of cost in the hospital process

    through study completion, an average of 3 month

  • Length of stay in the intensive care unit

    through study completion, an average of 3 month

  • Early extubation rate after two different neuromuscular blocking antagonist drugs

    through study completion, an average of 3 month

Study Arms (2)

Group Neostigmine

Group Sugammadex

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Among the patients who underwent cranial surgery under sevoflurane anesthesia and whose neuromuscular blockade was provided with rocuronium, the patients whose neuromuscular blockade was antagonized with neostigmine or sugammadex and who were admitted to the intensive care unit postoperatively were evaluated.

You may qualify if:

  • Patients from the American Society of Anesthesiology (ASA) I-II-III group,
  • over the age of 18,
  • who underwent elective surgery,
  • underwent general anesthesia with sevoflurane anesthesia from volatile anesthetics,
  • used rocuronium as a neuromuscular blocking agent

You may not qualify if:

  • Patients aged 18 and under,
  • ASA IV and above,
  • who underwent surgery under emergency conditions,
  • who have incomplete follow-up form records and electronic media data,
  • who were taken to the intensive care unit without neuromuscular blockade antagonism due to long surgery,
  • who were treated with a neuromuscular blocking agent other than rocuronium,
  • who were treated with a volatile anesthetic other than sevoflurane or with total intravenous anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 23, 2025

Study Start

May 1, 2021

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations