Postoperative ComplicationsPOMPONCT04371588
Perioperative Muscle Relaxant and Postoperative Outcomes
An observational study of Postoperative Complications, run by Air Force Military Medical University, China at 9 sites in China.
Trial summary
Muscle relaxant is usually needed for surgery. However, the optimal depth of neuro-muscular blockade is still on debate. Deep neuro-muscular blockade may benefit the patients during surgery, but may increase the risk of residual blockade after surgery. Residual blockade has been reported to increase risk of morbidity. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- No Response to Train of Four Stimulation and 1-2 Response to Train of Four Stimulation
- How many people
- 999 participants
- Where
- 9 sitesChina
- Study dates
- 17 Mar 2018to 12 Aug 2021
- Phase
- Observational
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for laparoscopic surgery are consecutively screened with inclusion and exclusion criteria.
Who may be able to join
- Age ≥18 years old
- Body mass <18 kg/m2
- American Society of Anesthesiologists status I-II
- Patients scheduled for elective laparoscopic colorectal or urological surgery
- Patients received general anesthesia and muscle relaxant
- Patients with written informed consent.
Who cannot join
- Second surgery during the same admission.
- Outpatient surgery
- Retroperitoneal laparoscopic surgery
- Patients scheduled for mechanical ventilation after surgery
- Patients scheduled for muscle relaxant other than rocuronium
- Patients with pregnancy or planned for breeding
- Patients who are involved in other studies
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
First hospital of Beijing University
Beijing, Beijing Municipality
Huaxi Hospital
Chengdu, Sichuan
Xiehe Hospital of Fujian Medical University
Fuzhou, Fujian
People's Hospital of Jiangsu
Nanjing
Ruijin Hospital
Shanghai, Shanghai Municipality
General hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Tongji Hospital of Tongji Medical School
Wuhan, Hubei
Xiehe Hospital of Tongji Medical School
Wuhan, Hubei
First Afiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Effect of Perioperative Muscle Relaxant Model on Postoperative Outcomes in Chinese Patients
Muscle relaxant is usually needed for surgery. However, the optimal depth of neuro-muscular blockade is still on debate. Deep neuro-muscular blockade may benefit the patients during surgery, but may increase the risk of residual blockade after surgery. Residual blockade has been reported to increase risk of morbidity. In this study, we tend to observe the postoperative outcomes in patients undergoing abdominal surgery under general anesthesia. And to compare the outcomes in patients received different depth of neuro-muscular blockade.
- Conditions
- Postoperative Complications
- Being tested
- No Response to Train of Four Stimulation, 1-2 Response to Train of Four Stimulation
- Keywords
- muscle relaxant, general anesthesia, Chinese patient
- Medical subject headings
- Postoperative Complications, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Response to Train of Four StimulationOther
No response is observed during Train of Four stimulation monitoring during surgery
1-2 Response to Train of Four StimulationOther
1 to 2 response is observed during Train of Four stimulation monitoring during surgery
| Study group | Role | What they receive |
|---|---|---|
| Deep neuro-muscular blockade | Not described Receives: Other: No Response to Train of Four Stimulation | |
| Moderate neuro-muscular blockade | Not described Receives: Other: 1-2 Response to Train of Four Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale of pain at rest at 24 hours after surgery
The intensity of pain is reported by the patient by provide a number between 0 and 10. 0 means no pain, and 10 means unbearable pain. Higher score means stronger pain.
Measured: from end of surgery to 24 hours after surgery
Visual Analogue Scale of pain at cough at 24 hours after surgery
The intensity of pain is reported by the patient by provide a number between 0 and 10. 0 means no pain, and 10 means unbearable pain. Higher score means stronger pain.
Measured: from end of surgery to 24 hours after surgery
Secondary outcomes (5)
Incidence of patients suffering pain at 24 hours after surgery
Measured: from end of surgery to 24 hours after surgery
Time to flatus
Measured: from end of surgery to flatus, on an average of 3 days
Time to extubation of the endotracheal tube
Measured: from end of surgery to removal of the endotracheal tube, on an average of 15 minutes
Incidence of major postoperative complications
Incidence of major postoperative complications (including myocardial ischemia, pulmonary infection, respiratory failure, brain ischemia)
Measured: from end of surgery to discharge from the hospital, on an average of 5 days
Satisfaction score of the Surgeon to the condition during surgery
The satisfaction of the Surgeon is measured by a scale from 0-10. 0 is for extremely unsatisfied, 10 is for totally satisfied. Higher score means higher satisfaction. The surgeon is asked to give a number between 0 and 10 to describe his satisfaction.
Measured: from start of surgery to end of surgery, on an average of 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start17 Mar 2018
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371588
- Sponsor's protocol ID
- XJH-A-20290110
- Acronym
- POMPO
- Status last verified
- Aug 2022
- First submitted
- 27 Apr 2020
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360.
PubMed 26479510Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.
PubMed 27936214
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Muscle Relaxant Model on Postoperative Outcomes in Chinese Patients
- ClinicalTrials.gov ID
- NCT04371588
- Acronym / sponsor ID
- POMPO / XJH-A-20290110
- Conditions
- Postoperative Complications
- Keywords
- muscle relaxant, general anesthesia, Chinese patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 17 Mar 2018 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 1 May 2020 (actual)
- 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.
Muscle relaxant is usually needed for surgery. However, the optimal depth of neuro-muscular blockade is still on debate. Deep neuro-muscular blockade may benefit the patients during surgery, but may increase the risk of residual blockade after surgery. Residual blockade has been reported to increase risk of morbidity. In this study, we tend to observe the postoperative outcomes in patients undergoing abdominal surgery under general anesthesia. And to compare the outcomes in patients received different depth of neuro-muscular blockade.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuro-muscular blockade | – | Other: No Response to Train of Four Stimulation |
| Moderate neuro-muscular blockade | – | Other: 1-2 Response to Train of Four Stimulation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for laparoscopic surgery are consecutively screened with inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- Age ≥18 years old
- Body mass <18 kg/m2
- American Society of Anesthesiologists status I-II
- Patients scheduled for elective laparoscopic colorectal or urological surgery
- Patients received general anesthesia and muscle relaxant
Key exclusion criteria (7 listed)
- Second surgery during the same admission.
- Outpatient surgery
- Retroperitoneal laparoscopic surgery
- Patients scheduled for mechanical ventilation after surgery
- Patients scheduled for muscle relaxant other than rocuronium
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 |
|---|---|---|
| No Response to Train of Four StimulationNo response is observed during Train of Four stimulation monitoring during surgery | Other | Deep neuro-muscular blockade |
| 1-2 Response to Train of Four Stimulation1 to 2 response is observed during Train of Four stimulation monitoring during surgery | Other | Moderate neuro-muscular blockade |
Primary outcome
Visual Analogue Scale of pain at rest at 24 hours after surgery
Time frame: from end of surgery to 24 hours after surgery
The intensity of pain is reported by the patient by provide a number between 0 and 10. 0 means no pain, and 10 means unbearable pain. Higher score means stronger pain.
Visual Analogue Scale of pain at cough at 24 hours after surgery
Time frame: from end of surgery to 24 hours after surgery
The intensity of pain is reported by the patient by provide a number between 0 and 10. 0 means no pain, and 10 means unbearable pain. Higher score means stronger pain.
5 secondary outcomes
Incidence of patients suffering pain at 24 hours after surgery
Time frame: from end of surgery to 24 hours after surgery
Time to flatus
Time frame: from end of surgery to flatus, on an average of 3 days
Time to extubation of the endotracheal tube
Time frame: from end of surgery to removal of the endotracheal tube, on an average of 15 minutes
Incidence of major postoperative complications
Time frame: from end of surgery to discharge from the hospital, on an average of 5 days
Satisfaction score of the Surgeon to the condition during surgery
Time frame: from start of surgery to end of surgery, on an average of 2.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 26479510Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360.
- Background: PubMed 27936214Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Air Force Military Medical University, China at 9 sites in China.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale of pain at rest at 24 hours after surgery (time frame: from end of surgery to 24 hours after surgery). The study lists 2 primary outcomes in all. 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 NCT04371588, which also lists 2 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 2 Sep 2022.