Sugammadex in different weights for motor block antagonism of bariatric surgery - clinical trial

Sugammadex in ideal weight versus weight for reversal of neuromuscular blockade in surgery for treatment of morbid obesity - double blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-7ms62x

Enrollment

Unknown

Registered

2016-06-14

Start date

2015-01-25

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

bariatric surgery , obesity, anesthesia , anesthetic adjuvants

Interventions

A prospectively double blind randomized clinical trial was done with sixty adults exhibiting BMI more than 40 Kg.m-2, scheduled for laparoscopic bariatric surgery. Subjects were randomly assigned to t

Drug

Procedure/surgery

E02.065.062

D27.505.954.427.010

Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Both genders, age between 18 and 65. BMI greater than or equal to 40 kg m -2, only included after signing the written informed consent

Exclusion criteria

Exclusion criteria: known neuromuscular diseases (eg Miastenis Gravis ) Use of drugs that interfere with the transmission neuromuscularAlergia to some of the drugs used in the study renal failure

Design outcomes

Primary

Measure	Time frame
Complete reversal of neuromuscular blockade by sugammadex . After completion of the last suture line in the abdominal wall and recovery from the second TOF response (T2), the blockade was reversed using a dose of 2 mg.Kg-1 sugammadex, based on three different body weight calculations — ideal, 20% corrected and 40% corrected — according to group. Blockade reversal was conducted by a research assistant aware of which group the participant was assigned. He prepared a syringe with the dose of sugammadex, according to the weight parameter established for that particular group. The syringe was further filled up with 0.9% physiological saline to a total volume of 10 ml, in such a way that the main researcher was unaware of the dose being administered and, hence, of the group to which the patient had been assigned. After initiation of injection of sugammadex, the neuromuscular functioning monitor continually measured TOF every 12 seconds. The time taken to reverse the blockade was measured from the beginning of injection using a digital stop watch and the TOF-Watch® SX program. Full neuromuscular reversal was defined as a TOF rate equal to or greater than 0.9 on three consecutive measurements. The reversal time as recorded as the first of these three measurements. The hypothesis was that Sugammadex effects swifter reversal of neuromuscular blockade, when administered at a dose calculated on the basis of ideal weight plus 40% of excess weight. ;Complete reversal of neuromuscular blockade by sugammadex . After completion of the last suture line in the abdominal wall and recovery from the second TOF response (T2), the blockade was reversed using a dose of 2 mg.Kg-1 sugammadex, based on three different body weight calculations — ideal, 20% corrected and 40% corrected — according to group. Blockade reversal was conducted by a research assistant aware of which group the participant was assigned. He prepared a syringe with the dose of sugammadex, according to the weight paramete	—

Measure

Time frame

Complete reversal of neuromuscular blockade by sugammadex . After completion of the last suture line in the abdominal wall and recovery from the second TOF response (T2), the blockade was reversed using a dose of 2 mg.Kg-1 sugammadex, based on three different body weight calculations — ideal, 20% corrected and 40% corrected — according to group. Blockade reversal was conducted by a research assistant aware of which group the participant was assigned. He prepared a syringe with the dose of sugammadex, according to the weight parameter established for that particular group. The syringe was further filled up with 0.9% physiological saline to a total volume of 10 ml, in such a way that the main researcher was unaware of the dose being administered and, hence, of the group to which the patient had been assigned. After initiation of injection of sugammadex, the neuromuscular functioning monitor continually measured TOF every 12 seconds. The time taken to reverse the blockade was measured from the beginning of injection using a digital stop watch and the TOF-Watch® SX program. Full neuromuscular reversal was defined as a TOF rate equal to or greater than 0.9 on three consecutive measurements. The reversal time as recorded as the first of these three measurements. The hypothesis was that Sugammadex effects swifter reversal of neuromuscular blockade, when administered at a dose calculated on the basis of ideal weight plus 40% of excess weight. ;Complete reversal of neuromuscular blockade by sugammadex . After completion of the last suture line in the abdominal wall and recovery from the second TOF response (T2), the blockade was reversed using a dose of 2 mg.Kg-1 sugammadex, based on three different body weight calculations — ideal, 20% corrected and 40% corrected — according to group. Blockade reversal was conducted by a research assistant aware of which group the participant was assigned. He prepared a syringe with the dose of sugammadex, according to the weight paramete

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Secondary

Measure	Time frame
Occurrence of residual curarization in the post-anesthesia recovery room. After awakening from anesthesia, tracheal extubation and ensuring adequate conditions for transfer from the operating theater, each patient was referred to the post-anesthesia care unit (PACU), where they remained for at least two hours and were evaluated for appearance and need for treatment of clinical signs of muscular weakness and other routine procedures of such units. Clinical tests were carried out on leaving the operating theater, every 20 minutes at PACU and immediately prior to being moved from PACU to the ward, searching the patient's ability to pass from the surgical bed to the transport with little or no help, adequacy of oxigenation, respiratory pattern, ability to swallow saliva and clarity of vision. The expected was that the group Sugammadex the ideal weight presented higher frequency of occurrence of postoperative residual neuromuscular blockade in the post- anesthetic recovery room . ;Occurrence of residual curarization in the post-anesthesia recovery room. After awakening from anesthesia, tracheal extubation and ensuring adequate conditions for transfer from the operating theater, each patient was referred to the post-anesthesia care unit (PACU), where they remained for at least two hours and were evaluated for appearance and need for treatment of clinical signs of muscular weakness and other routine procedures of such units. Clinical tests were carried out on leaving the operating theater, every 20 minutes at PACU and immediately prior to being moved from PACU to the ward, searching the patient's ability to pass from the surgical bed to the transport with little or no help, adequacy of oxigenation, respiratory pattern, ability to swallow saliva and clarity of vision. No differences were observed between the groups in terms of frequency of postoperative residual curarization	—

Measure

Time frame

Occurrence of residual curarization in the post-anesthesia recovery room. After awakening from anesthesia, tracheal extubation and ensuring adequate conditions for transfer from the operating theater, each patient was referred to the post-anesthesia care unit (PACU), where they remained for at least two hours and were evaluated for appearance and need for treatment of clinical signs of muscular weakness and other routine procedures of such units. Clinical tests were carried out on leaving the operating theater, every 20 minutes at PACU and immediately prior to being moved from PACU to the ward, searching the patient's ability to pass from the surgical bed to the transport with little or no help, adequacy of oxigenation, respiratory pattern, ability to swallow saliva and clarity of vision. The expected was that the group Sugammadex the ideal weight presented higher frequency of occurrence of postoperative residual neuromuscular blockade in the post- anesthetic recovery room . ;Occurrence of residual curarization in the post-anesthesia recovery room. After awakening from anesthesia, tracheal extubation and ensuring adequate conditions for transfer from the operating theater, each patient was referred to the post-anesthesia care unit (PACU), where they remained for at least two hours and were evaluated for appearance and need for treatment of clinical signs of muscular weakness and other routine procedures of such units. Clinical tests were carried out on leaving the operating theater, every 20 minutes at PACU and immediately prior to being moved from PACU to the ward, searching the patient's ability to pass from the surgical bed to the transport with little or no help, adequacy of oxigenation, respiratory pattern, ability to swallow saliva and clarity of vision. No differences were observed between the groups in terms of frequency of postoperative residual curarization

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Countries

Brazil

Contacts

Public ContactNádia Duarte

Hospital das Clínicas da Universidade Federal de Pernambuco (UFPE)

nadiaduarte2011@gmail.com5581999757949

Outcome results

None listed

Source: REBEC (via WHO ICTRP)