Morbid ObesitySugamadexNCT01564576
Neuromuscular Blockade and Surgical Conditions
A study testing Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion) in people with Morbid Obesity, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of the present study is to prospectively assess whether deep neuromuscular blockade (NMB) (zero response to train of four and a post tetanic count of no more than 10 responses using a nerve stimulator monitoring) until the end of surgery, followed by sugammadex (bridion®) reversal is superior to the present… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status Class I-III, scheduled to undergo elective sleeve gastrectomy
Who cannot join
- Neuromuscular disorder affecting NMB
- history of malignant hyperthermia
- significant renal dysfunction
- allergy to medications used during general anesthesia
- concurrent use of medications known to interfere with NMBAs or with sugammadex (antibiotics, anticonvulsants, magnesium salts).
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Tel HaShomer
Haim Berkenstadt, MD, 97235302966 ext. 2966, haim.berkenstadt@sheba.health.gov.il
Haim Berkenstadt, MD
About this study
Official title: The Influence of the Magnitude of Neuromuscular Blockade on the Surgical Conditions During Laparoscopic Sleeve Gastrectomy
The aim of the present study is to prospectively assess whether deep neuromuscular blockade (NMB) (zero response to train of four and a post tetanic count of no more than 10 responses using a nerve stimulator monitoring) until the end of surgery, followed by sugammadex (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end of surgery followed by neostigmine (Prostigmin®, Vagostigmin®) reversal, in patients undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing deep NMB throughout the procedure creates better conditions for surgery, while reversal of deep NMBwith sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer postoperative respiratory events as compared to neostigmine (Prostigmin®, Vagostigmin®)reversal. Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Read the detailed description
In laparoscopic bariatric procedures, CO2 is used to insufflate the peritoneal cavity and increase the intra-abdominal pressure for optimal exposure and a suitable operating field. However, the increased intra-abdominal pressure during pneumoperitoneum has profound physiological effects including a reduction in urine output,portal venous flow,respiratory compliance,and cardiac output.
Abdominal muscle relaxation and changes in abdominal wall compliance, produced by the use of anesthetics and muscle relaxants, are important contributors for the achievement of optimal surgical field using minimal abdominal pressure. A practical dilemma is how to maintain good surgical conditions till the end of the operative procedure by deep anesthesia and muscle relaxation on one hand, and to have an awake and spontaneously breathing patient at the end of surgery on the other.
Reversal agents are often used to ensure the reversal of nondepolarizing neuromuscular blockade (NMB). The most widely used is the acetylcholinesterase inhibitor neostigmine (Prostigmin®, Vagostigmin®). However, neostigmine is only partially effective when NMB is deep (less then 1 response using train of four monitoring) and may also be associated with adverse effects, such as cholinergic cardiovascular and gastrointestinal events.Sugammadex (bridion®) is a modified gamma cyclodextrin specifically designed for the reversal of NMB induced by the aminosteroid muscle relaxants including rocuronium bromide (Zemuron®, Esmeron®). Sugammadex (bridion®) acts by encapsulating unbound rocuronium bromide (Zemuron®, Esmeron®)molecules and reducing their concentration at the neuromuscular junction.Studies in surgical patients have shown that sugammadex (bridion®) rapidly and safely reverses rocuronium bromide (Zemuron®, Esmeron®)induced NMB. Unlike acetylcholinesterase inhibitors, sugammadex (bridion®) is also effective in the reversal of deep NMB (no response in train of four monitoring or even no response in post tetanic count monitoring).
Laparoscopic weight reduction surgery requires the appropriate use of muscle relaxation; however, uncertainty remains including indeterminate dosing and unpredictable effect. Additionally, the time to the recovery to a train of four (TOF) ratio of 0.9 in the obese [25.9 (6.7, 13.5-41.0) min] and the overweight groups [14.6 (7.7, 3.3-28.5) min] were significantly longer than that in the normal weight group [6.9 (2.0, 3.0-10.7) min]. Therefore, obese patients are at increased risk for residual muscle relaxation following surgery. Sugammadex (bridion®) has recently been found to reach a peak effect faster than neostigmine(Prostigmin®, Vagostigmin®), in obese patients. In this study, the time to a TOFR ≥ 0.9 was 13 min with 50 μg/kg neostigmine (Prostigmin®, Vagostigmin®)and only 1.7 min with 2 mg/kg sugammadex. Therefore, it appears that sugammadex (bridion®) may more predictably prevent the occurrence of residual muscle relaxation compared to neostigmine (Prostigmin®, Vagostigmin®).
The aim of the present study is to prospectively assess whether deep NMB (zero response to train of four and a post tetanic count of no more than 10 responses using a nerve stimulator monitoring) till the end of surgery, followed by sugammadex (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end of surgery followed by neostigmine (Prostigmin®, Vagostigmin®)reversal, in patients undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing deep NMB throughout the procedure creates better conditions for surgery, while reversal of deep muscle relaxation with sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer postoperative respiratory events as compared to neostigmine (Prostigmin®, Vagostigmin®) reversal. Surgical conditions will be assessed by the surgeons, blinded to the treatment given to the patients, on a 1-4 Likert scale in 5 minutes intervals from abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes). Participants will be followed for respiratory adverse events from admission to the post anesthesia care unit to discharge to the surgical department (continuous measurement of hemoglobin oxygen saturation and respiratory rate for an expected average of 3 hours) and from admission to the surgical department till the time of home discharge (measurement of hemoglobin oxygen saturation and respiratory rate every 6 hours for an expected average of 5 days).
- Conditions
- Morbid Obesity
- Being tested
- Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)
- Keywords
- Laparoscopic surgery, Anesthesiology, Neuromuscular blockade
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)Drug
Also called Rocuronium, Rocuronium bromide, sugammadex, Bridion
Rocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses. At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12. Extubation will be performed when train-of-four ratios ≥ 0.9.
| Study group | Role | What they receive |
|---|---|---|
| Conventional neuromuscular blockade | No intervention | The dose of rocuronium (medication used for NMB during anesthesia)will be adjusted to maintain a depth of NMB of T1 of 10-20% as assessed by a nerve stimulator. At the end of surgery patients will receive neostigmine 2.5 mg and atropine 1 mg to reverse the effect of rocuronium. Extubation will be performed when train-of-four ratio ≥ 0.9. Receives: Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion) |
| Profound neuromuscular blockade | Experimental | Rocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses. At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12. Extubation will be performed when train-of-four ratios ≥ 0.9. Receives: Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective surgeon feedback on the exposure and surgical field.
The surgeons blinded to the treatment given to the patients will be asked to assess the quality of the surgical fiels using 1-4 likert scale
Measured: From abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes).
Secondary outcomes (1)
Incidence of respiratory adverse events
The incidence of respiratory events including- hypoxemia (defined as hemoglobin oxygen saturation lower then 92% while breathing room air), pneumonia (elevated body temperature and findings in chest x-ray), and the need for non invasive or invasive mechanical ventilation; will be assessed continuously during the post anesthesia care unit stay and on 6 hours intervals during the surgical department stay.
Measured: From admission to the post anesthesia care unit till discharge to the surgical department (expected average of 3 hours) and from admission to the surgical department till the time of home discharge (expected average of 5 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Haim Berkenstadt, Sheba Medical Center
- Investigators
- Haim Berkenstadt, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564576
- Sponsor's protocol ID
- SHEBA-12-9237-HB-CTIL
- Acronym
- Sugamadex
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Daskalakis M, Scheffel O, Weiner RA. High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Obes Facts. 2009;2 Suppl 1(Suppl 1):37-40. doi: 10.1159/000198252. Epub 2009 Mar 18.
PubMed 20124777Matot I, Paskaleva R, Eid L, Cohen K, Khalaileh A, Elazary R, Keidar A. Effect of the volume of fluids administered on intraoperative oliguria in laparoscopic bariatric surgery: a randomized controlled trial. Arch Surg. 2012 Mar;147(3):228-34. doi: 10.1001/archsurg.2011.308. Epub 2011 Nov 21.
PubMed 22106246Nsadi B, Gilson N, Pire E, Cheramy JP, Pincemail J, Scagnol I, Meurisse M, Defraigne JO, Detry O. Consequences of pneumoperitoneum on liver ischemia during laparoscopic portal triad clamping in a swine model. J Surg Res. 2011 Mar;166(1):e35-43. doi: 10.1016/j.jss.2010.10.033. Epub 2010 Nov 24.
PubMed 21176920Fahy BG, Barnas GM, Nagle SE, Flowers JL, Njoku MJ, Agarwal M. Changes in lung and chest wall properties with abdominal insufflation of carbon dioxide are immediately reversible. Anesth Analg. 1996 Mar;82(3):501-5. doi: 10.1097/00000539-199603000-00013.
PubMed 8623951Popescu WM, Bell R, Duffy AJ, Katz KH, Perrino AC Jr. A pilot study of patients with clinically severe obesity undergoing laparoscopic surgery: evidence for impaired cardiac performance. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):943-9. doi: 10.1053/j.jvca.2010.11.012. Epub 2011 Jan 12.
PubMed 21232976Suy K, Morias K, Cammu G, Hans P, van Duijnhoven WG, Heeringa M, Demeyer I. Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. Anesthesiology. 2007 Feb;106(2):283-8. doi: 10.1097/00000542-200702000-00016.
PubMed 17264722
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Magnitude of Neuromuscular Blockade on the Surgical Conditions During Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT01564576
- Acronym / sponsor ID
- Sugamadex / SHEBA-12-9237-HB-CTIL
- Conditions
- Morbid Obesity
- Keywords
- Laparoscopic surgery, Anesthesiology, Neuromuscular blockade
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to prospectively assess whether deep neuromuscular blockade (NMB) (zero response to train of four and a post tetanic count of no more than 10 responses using a nerve stimulator monitoring) until the end of surgery, followed by sugammadex (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end of surgery followed by neostigmine (Prostigmin®, Vagostigmin®) reversal, in patients undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing deep NMB throughout the procedure creates better conditions for surgery, while reversal of deep NMBwith sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer postoperative respiratory events as compared to neostigmine (Prostigmin®, Vagostigmin®)reversal. Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Detailed description
In laparoscopic bariatric procedures, CO2 is used to insufflate the peritoneal cavity and increase the intra-abdominal pressure for optimal exposure and a suitable operating field. However, the increased intra-abdominal pressure during pneumoperitoneum has profound physiological effects including a reduction in urine output,portal venous flow,respiratory compliance,and cardiac output.
Abdominal muscle relaxation and changes in abdominal wall compliance, produced by the use of anesthetics and muscle relaxants, are important contributors for the achievement of optimal surgical field using minimal abdominal pressure. A practical dilemma is how to maintain good surgical conditions till the end of the operative procedure by deep anesthesia and muscle relaxation on one hand, and to have an awake and spontaneously breathing patient at the end of surgery on the other.
Reversal agents are often used to ensure the reversal of nondepolarizing neuromuscular blockade (NMB). The most widely used is the acetylcholinesterase inhibitor neostigmine (Prostigmin®, Vagostigmin®). However, neostigmine is only partially effective when NMB is deep (less then 1 response using train of four monitoring) and may also be associated with adverse effects, such as cholinergic cardiovascular and gastrointestinal events.Sugammadex (bridion®) is a modified gamma cyclodextrin specifically designed for the reversal of NMB induced by the aminosteroid muscle relaxants including rocuronium bromide (Zemuron®, Esmeron®). Sugammadex (bridion®) acts by encapsulating unbound rocuronium bromide (Zemuron®, Esmeron®)molecules and reducing their concentration at the neuromuscular junction.Studies in surgical patients have shown that sugammadex (bridion®) rapidly and safely reverses rocuronium bromide (Zemuron®, Esmeron®)induced NMB. Unlike acetylcholinesterase inhibitors, sugammadex (bridion®) is also effective in the reversal of deep NMB (no response in train of four monitoring or even no response in post tetanic count monitoring).
Laparoscopic weight reduction surgery requires the appropriate use of muscle relaxation; however, uncertainty remains including indeterminate dosing and unpredictable effect. Additionally, the time to the recovery to a train of four (TOF) ratio of 0.9 in the obese [25.9 (6.7, 13.5-41.0) min] and the overweight groups [14.6 (7.7, 3.3-28.5) min] were significantly longer than that in the normal weight group [6.9 (2.0, 3.0-10.7) min]. Therefore, obese patients are at increased risk for residual muscle relaxation following surgery. Sugammadex (bridion®) has recently been found to reach a peak effect faster than neostigmine(Prostigmin®, Vagostigmin®), in obese patients. In this study, the time to a TOFR ≥ 0.9 was 13 min with 50 μg/kg neostigmine (Prostigmin®, Vagostigmin®)and only 1.7 min with 2 mg/kg sugammadex. Therefore, it appears that sugammadex (bridion®) may more predictably prevent the occurrence of residual muscle relaxation compared to neostigmine (Prostigmin®, Vagostigmin®).
The aim of the present study is to prospectively assess whether deep NMB (zero response to train of four and a post tetanic count of no more than 10 responses using a nerve stimulator monitoring) till the end of surgery, followed by sugammadex (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end of surgery followed by neostigmine (Prostigmin®, Vagostigmin®)reversal, in patients undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing deep NMB throughout the procedure creates better conditions for surgery, while reversal of deep muscle relaxation with sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer postoperative respiratory events as compared to neostigmine (Prostigmin®, Vagostigmin®) reversal. Surgical conditions will be assessed by the surgeons, blinded to the treatment given to the patients, on a 1-4 Likert scale in 5 minutes intervals from abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes). Participants will be followed for respiratory adverse events from admission to the post anesthesia care unit to discharge to the surgical department (continuous measurement of hemoglobin oxygen saturation and respiratory rate for an expected average of 3 hours) and from admission to the surgical department till the time of home discharge (measurement of hemoglobin oxygen saturation and respiratory rate every 6 hours for an expected average of 5 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional neuromuscular blockade | No intervention | Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)The dose of rocuronium (medication used for NMB during anesthesia)will be adjusted to maintain a depth of NMB of T1 of 10-20% as assessed by a nerve stimulator. At the end of surgery patients will receive neostigmine 2.5 mg and atropine 1 mg to reverse the effect of rocuronium. Extubation will be performed when train-of-four ratio ≥ 0.9. |
| Profound neuromuscular blockade | Experimental | Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)Rocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses. At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12. Extubation will be performed when train-of-four ratios ≥ 0.9. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status Class I-III, scheduled to undergo elective sleeve gastrectomy
Key exclusion criteria (5 listed)
- Neuromuscular disorder affecting NMB
- history of malignant hyperthermia
- significant renal dysfunction
- allergy to medications used during general anesthesia
- concurrent use of medications known to interfere with NMBAs or with sugammadex (antibiotics, anticonvulsants, magnesium salts).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)Also: Rocuronium, Rocuronium bromide, sugammadex, BridionRocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses. At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12. Extubation will be performed when train-of-four ratios ≥ 0.9. | Drug | Conventional neuromuscular blockade, Profound neuromuscular blockade |
Primary outcome
Subjective surgeon feedback on the exposure and surgical field.
Time frame: From abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes).
The surgeons blinded to the treatment given to the patients will be asked to assess the quality of the surgical fiels using 1-4 likert scale
1 secondary outcome
Incidence of respiratory adverse events
Time frame: From admission to the post anesthesia care unit till discharge to the surgical department (expected average of 3 hours) and from admission to the surgical department till the time of home discharge (expected average of 5 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- Background: PubMed 20124777Daskalakis M, Scheffel O, Weiner RA. High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Obes Facts. 2009;2 Suppl 1(Suppl 1):37-40. doi: 10.1159/000198252. Epub 2009 Mar 18.
- Background: PubMed 22106246Matot I, Paskaleva R, Eid L, Cohen K, Khalaileh A, Elazary R, Keidar A. Effect of the volume of fluids administered on intraoperative oliguria in laparoscopic bariatric surgery: a randomized controlled trial. Arch Surg. 2012 Mar;147(3):228-34. doi: 10.1001/archsurg.2011.308. Epub 2011 Nov 21.
- Background: PubMed 21176920Nsadi B, Gilson N, Pire E, Cheramy JP, Pincemail J, Scagnol I, Meurisse M, Defraigne JO, Detry O. Consequences of pneumoperitoneum on liver ischemia during laparoscopic portal triad clamping in a swine model. J Surg Res. 2011 Mar;166(1):e35-43. doi: 10.1016/j.jss.2010.10.033. Epub 2010 Nov 24.
- Background: PubMed 8623951Fahy BG, Barnas GM, Nagle SE, Flowers JL, Njoku MJ, Agarwal M. Changes in lung and chest wall properties with abdominal insufflation of carbon dioxide are immediately reversible. Anesth Analg. 1996 Mar;82(3):501-5. doi: 10.1097/00000539-199603000-00013.
- Background: PubMed 21232976Popescu WM, Bell R, Duffy AJ, Katz KH, Perrino AC Jr. A pilot study of patients with clinically severe obesity undergoing laparoscopic surgery: evidence for impaired cardiac performance. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):943-9. doi: 10.1053/j.jvca.2010.11.012. Epub 2011 Jan 12.
- Background: PubMed 17264722Suy K, Morias K, Cammu G, Hans P, van Duijnhoven WG, Heeringa M, Demeyer I. Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. Anesthesiology. 2007 Feb;106(2):283-8. doi: 10.1097/00000542-200702000-00016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haim Berkenstadt, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion) in people with Morbid Obesity, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haim Berkenstadt, MD (97235302966, haim.berkenstadt@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective surgeon feedback on the exposure and surgical field. (time frame: From abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01564576, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2012.