A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients
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ClinicalTrials.gov Identifier: NCT01761552 |
Recruitment Status : Unknown
Verified September 2012 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : January 4, 2013
Last Update Posted : September 10, 2013
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To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 & 4E patients
Primary endpoint:
• Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
Secondary endpoints:
• Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuromuscular Blockade | Drug: Sugammadex Reversal Drug: Atropine/Neostigmine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients. |
Study Start Date : | August 2013 |
Estimated Primary Completion Date : | December 2015 |

Arm | Intervention/treatment |
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Experimental: Sugammadex (tradename Bridion) |
Drug: Sugammadex Reversal |
Active Comparator: Traditional reversal or spontaneous recovery:
Atropine/Neostigmine: Atropine, 0.02 mg/ kg, and Neostigmine,0.05 mg/kg diluted in 100 ml Normal Saline and given over a 10 min drip. Reversal will be given only recommended if spontaneous recovery has occurred up to the reappearance of T2 (shallow blockade) following rocuronium induced blockade.
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Drug: Atropine/Neostigmine |
- Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred. [ Time Frame: 24 hours ]
- Time to extubation - measure the difference in time from application of the surgical dressing until extubation. [ Time Frame: 24 hours ]
- Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.) [ Time Frame: 24 hours ]
- The effect of Sugammadex on cortisol levels [ Time Frame: 72 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA 4 AND ASA 4E patients
- Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -
Exclusion Criteria:
- Patients ASA 1-3 or 5
- Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
- Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
- Hypersensitivity to the active substances or to any of the excipients of medications used
- Patients with severe renal impairment (including patients requiring dialysis (CrCl < 30mL/min))
- Patients with severe hepatic impairment
- Age < 18 years

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761552
Contact: Hadas Lemberg, PhD | 00 972 2 6777572 | lhadas@hadassah.org.il |
Israel | |
Hadassah Medical Organization | Recruiting |
Jerusalem, Israel, 91120 | |
Principal Investigator: Yoram Weiss, MD |
Principal Investigator: | Yoram G Weiss, MD | Hadassah Medical Organization |
Responsible Party: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT01761552 |
Other Study ID Numbers: |
0513-12-HMO |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | September 10, 2013 |
Last Verified: | September 2012 |
in ASA 4 AND ASA 4E patients |
Atropine Neostigmine Adjuvants, Anesthesia Anti-Arrhythmia Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
Mydriatics Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinesterase Inhibitors Enzyme Inhibitors Parasympathomimetics |