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Effect of sugammadex, reversing the effects of rocuronium, on steroid hormone levels

Effect of sugammadex on steroid hormone levels in male patients undergoing elective lower extremity surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000553673
Acronym
nil
Enrollment
50
Registered
2014-05-23
Start date
2014-01-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

In this study, the effect of sugammadex, a recently introduced alternative to traditional decurarization by cholinesterase inhibitors, on adrenal cortical hormones has been examined. After local ethics committee approval were obtained and written informed patient consent will obtain, a total of 50 male patients between 18 and 45 years of age with an ASA (American Anesthesiology Association) class of I or II undergoing elective lower extremity surgery with an expected surgery time of 1 to 3 hours will include in this study. Prior to surgery, patients will categorize into two groups (neostigmin group, Group N; and sugammadex group, Group S). In addition to standard monitorization, train-of-four (TOF ) is going to used to monitorize the level of neuromuscular blockade. Standard induction (propofol, rocuronium, remifentanyl) and maintenance (seovoflurane, O2) of anesthesia will perform. At the termination of surgery, neuromuscular blockade will antagonise using 0.05 mg/kg of neostigmine and 0.01 mg/kg of atropin in Group N and using 4 mg/kg sugammadex in Group S when spontaneous recovery of neuromuscular blockade occurs with the reappearance of T2. A total of three blood samples, just before and 15 minutes and 4 hours after antagonism, will obtain in each patient to determine serum aldosterone, cortisol, progesterone, and free testosterone levels.

Interventions

A total of 50 male patients between 18 and 45 years of age with an ASA (American Anesthesiology Association) class of I or II undergoing elective lower extremity surgery with an expected surgery time of 1 to 3 hours were planned to be in this study. Prior to surgery, patients are going to class into two groups (neostigmin group, Group N; and sugammadex group, Group S). In addition to standard monitoring, train-of-four (TOF) is going to use to monitor the level of neuromuscular blockade. Standard

A total of 50 male patients between 18 and 45 years of age with an ASA (American Anesthesiology Association) class of I or II undergoing elective lower extremity surgery with an expected surgery time of 1 to 3 hours were planned to be in this study. Prior to surgery, patients are going to class into two groups (neostigmin group, Group N; and sugammadex group, Group S). In addition to standard monitoring, train-of-four (TOF) is going to use to monitor the level of neuromuscular blockade. Standard induction (propofol, rocuronium, remifentanyl) and maintenance (seovoflurane, O2) of anesthesia will be performed. At the termination of surgery, neuromuscular blockade will be antagonised using 0.05 mg/kg of neostigmine (intravenous injection) and 0.01 mg/kg of atropin (intravenous injection) in Group N and using 4 mg/kg sugammadex (intravenous injection) in Group S when spontaneous recovery of neuromuscular blockade occurs with the reappearance of T2. A total of three blood samples, just before and 15 minutes and 4 hours after antagonism, will be obtained in each patient to determine serum aldosterone, cortisol, progesterone, and free testosterone levels.

Sponsors

Firat University Scientific Research Projects Unit
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Elective lower extremity surgery undergone general anesthesia ASA I-II Male patient 18-45 years of age expected surgery time is 1-3 hours

Exclusion criteria

ASA III, IV and V neuromuscular disease endocrin disease psychiatric, liver, kidney, heart diseases, diabetes mellitus and peripheral neuropathic diseases, co-operation difficulties, difficult intubation possibility, steroid or hormone therapy, obesity (body mass index> 30 kg/m2), neuromuscular blockers interact with drug use (such as magnesium)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026