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

Phase 4

Recruiting

• Conditions: anesthesia for lower extremity surgery; neuromuscular blockade; steroid hormones; Anaesthesiology - Anaesthetics; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12614000553673
• Lead Sponsor: Firat University Scientific Research Projects Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 50

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum aldosterone and free testosterone[1-just before neostigmine or sugammadex are given to the patient<br>2- at 15 minutes after neostigmine or sugammadex are given to the patient<br>3- at 4 hours after neostigmine or sugammadex are given to the patient<br>];serum cortisol level[1-just before neostigmine or sugammadex are given to the patient<br>2- at 15 minutes after neostigmine or sugammadex are given to the patient<br>3- at 4 hours after neostigmine or sugammadex are given to the patient<br>];serum progesterone level[1-just before neostigmine or sugammadex are given to the patient<br>2- at 15 minutes after neostigmine or sugammadex are given to the patient<br>3- at 4 hours after neostigmine or sugammadex are given to the patient<br>]

Secondary Outcome Measures

Name	Time	Method
times (minutes) which TOF ratio reachs to 0.7, 0.8 and 0.9 levels.[just after neostigmine or sugammadex are given];heart rate (via ECG)[every 5 minutes from induction of anaesthesia until discharge from post-anesthesia care unit. ];presence of postoperative hypotension, cough, nausea, vomiting, dry mouth, and abnormal smell sense <br><br>[just before transfer from the recovery room to the ward surgery];clinical signs and symptoms of postoperative residual block (to hold above head and leg, and handshake for 5 seconds, and tongue depressor test)[just before transfer from the recovery room to the ward surgery];mean arterial pressure (via noninvasive blood pressure)[every 5 minutes from induction of anaesthesia until discharge from post-anesthesia care unit. ];peripheric oxygen saturation (via pulse oximetry)[every 5 minutes from induction of anaesthesia until discharge from post-anesthesia care unit. ]