UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043518 |
|---|---|
| Receipt number | R000049690 |
| Scientific Title | Comparison of reversal with neostigmine vs. sugammadex for postoperative bowel function in patients undergoing colorectal surgery |
| Date of disclosure of the study information | 2021/09/14 |
| Last modified on | 2024/08/23 09:07:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of reversal with neostigmine vs. sugammadex for postoperative bowel function in patients undergoing colorectal surgery
Acronym
comparison of reversal with neostsigmine and sugammadex for post.op bowel function in patients undergoing colorectal surg.
Scientific Title
Comparison of reversal with neostigmine vs. sugammadex for postoperative bowel function in patients undergoing colorectal surgery
Scientific Title:Acronym
comparison of reversal with neostsigmine and sugammadex for post.op bowel function in patients undergoing colorectal surg.
Region
| Asia(except Japan) |
Condition
Condition
colorectal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the difference in bowel function after surgery between the patients receiving neostigmine as a muscle relaxation reversal and those receiving sugammadex in patients undergoing colorectal surgery under general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluating the time taken to expel gas in the first intestine after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sugammadex
Interventions/Control_2
neostigmine
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients in the American Society of Anesthesiology class 1 and 2
2. Patients planning colorectal surgery under general anesthesia
3. Patients with prior consent to the study
Key exclusion criteria
1. Patients who have been given drugs that affect muscle relaxation recovery (anticonvulsants, antidepressants, etc.)
2. Patients who had history of neuromuscular diseases
3. Patients with hypersensitivity to rocuronium, neostigmine, and sugammadex
4. Patients with liver disease (OT/PT> 40 IU/L), kidney disease (Cr> 1.4 mg/dl)
5. Patients with with bowel obstruction
6. Patients who disagree with the test
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | JINWOO |
| Middle name | |
| Last name | PARK |
Organization
Seoul national university Bundang hospital
Division name
Anesthesiology and pain medicine
Zip code
13620
Address
82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL
+82317873640
jinul8282@snubh.org
Public contact
Name of contact person
| 1st name | JIYOUN |
| Middle name | |
| Last name | LEE |
Organization
Seoul national university Bundang hospital
Division name
Anesthesiology and pain medicine
Zip code
13620
Address
82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL
+82317873640
Homepage URL
heykiki1@hanmail.net
Sponsor or person
Institute
self
Institute
Department
Personal name
Funding Source
Organization
MSD Korea Ltd.(MSD has decided to offer sugammadex drugs in-kind.)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul national university Bundang hospital
Address
172 Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Tel
+82317878801
snubhirb@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0952818024002174?dgcid=author
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0952818024002174?dgcid=author
Number of participants that the trial has enrolled
122
Results
The sugammadex group had a considerably shorter time to the first flatus than the neostigmine group (59 [42-79] h vs. 69 [53-90] h, P = 0.027). The time to first feces, as well as the incidences of postoperative nausea, vomiting, and ileus, were not different across the groups, nor was the postoperative duration of stay. The sugammadex group had a considerably decreased incidence of postoperative dry mouth compared to the neostigmine group (7 patients [13%] vs 39 patients [71%], P <0.001).
Results date posted
| 2024 | Year | 08 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We assessed patients demographic characteristics (age, sex, height, weight, BMI, ASA classification, HTN, DM, smoking history, serum calcium) and the operation and anesthesia parameters (anesthesia time, operation time, operation type, intraoperative remifentanil/rocuronium use, intraoperative fluid administration, estimated blood loss). Baseline covariates were generally balanced between the two groups, with ASD under 0.37 for all characteristics.
Participant flow
Of 130 patients assessed for eligibility, 122 were enrolled in the study. Excluding the patients who dropped out, 111 patients completed the study, with 56 and 55 in the sugammadex and neostigmine groups, respectively.
Adverse events
We assessed the incidences of nausea/vomiting, postoperative ileus, and dry mouth, which are common side effects after colon surgery. The incidences were comparable between the two groups.
Outcome measures
The primary outcome was the time to the first passage of flatus, recorded in hours from the injection of the reversal agent following operation completion. We also evaluated secondary outcomes during the postoperative recovery phase. To determine the time to first defecation after surgery, patients were asked to record their first defecation times. At 24 and 48 hours after surgery, a blinded researcher visited the patients and rated their postoperative pain using the visual analog scale (0 - 10; 0: no pain, 10: the worst). The study also looked at the rates of surgical complications (nausea or vomiting, as well as dry mouth) in the first 48 hours. The amount of fentanyl delivered postoperatively (including bolus injections and patient-controlled analgesia) and the number of rescue analgesic treatments were documented 48 hours after surgery. Postoperative ileus was characterized as a radiologic confirmation on or after postoperative day four without flatus or feces after surgery. Finally, the duration of the postoperative hospital stay was documented. Except for the first flatus time and dry mouth, no significant differences were observed between the two groups in any of the other measured parameters.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049690
