RecruitingPhase 4ACTRN12614000553673

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


Sponsor

Firat University Scientific Research Projects Unit

Enrollment

50 participants

Start Date

Jan 1, 2014

Study Type

Interventional

Conditions

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.


Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

After surgery, patients are given medications to reverse muscle relaxants used during anaesthesia. This study is comparing two reversal agents — neostigmine (the traditional drug) and sugammadex (a newer option) — to see whether sugammadex affects hormone levels, specifically cortisol, aldosterone, progesterone, and testosterone. Blood samples will be collected before and after reversal to compare the two approaches. You may be eligible if: - You are a male between 18 and 45 years old - You are having elective lower limb surgery under general anaesthesia - Your expected surgery time is between 1 and 3 hours - You are in good general health (ASA class I or II) You may NOT be eligible if: - You have a neuromuscular disease, endocrine disorder, or psychiatric condition - You have liver, kidney, heart, or peripheral nerve disease - You have diabetes mellitus - You are obese (BMI over 30 kg/m²) - You are on steroid or hormone therapy - You are taking any medications that interact with neuromuscular blockers Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Elazig, Turkey

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ACTRN12614000553673