Hernia Abdominal WallNCT04022733

Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy

A study testing Moderate neuromuscular block and Deep neuromuscular block in people with Hernia Abdominal Wall, run by Ajou University School of Medicine at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to compare the remifentanil requirements in deep versus moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic herniorrhaphy. Read more about this study

Who is it for?: Ages 19 to 85 years
Conditions the study is for: Hernia Abdominal Wall
What is being tested?: Moderate neuromuscular block and Deep neuromuscular block
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 134 participants
Where: 1 siteSouth Korea
Study dates: 30 Oct 2019to 3 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

laparoscopic hernia repair

Who cannot join

patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Gyeonggido

Other trials in South Korea

About this study

Official title: A Double-blind, Randomized Study to Compare the Remifentanil Requirements in Deep Versus Moderate Neuromuscular Blocks During the Surgical Pleth Index-guided Analgesia in Patients Undergoing General Anesthesia for Laparoscopic Herniorrhaphy

Conditions: Hernia Abdominal Wall
Being tested: Moderate neuromuscular block, Deep neuromuscular block
Medical subject headings: Hernia, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moderate neuromuscular blockDrug
maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
Deep neuromuscular blockDrug
maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight

Study groups in NCT04022733
Study group	Role	What they receive
Moderate NMB group	Placebo comparator	Not described Receives: Drug: Moderate neuromuscular block
Deep NMB group	Experimental	Not described Receives: Drug: Deep neuromuscular block

What is being measured

The primary outcome is the main question the study is designed to answer.

Remifentanil Infusion Rate
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50
Measured: from pneumoperitoneum to removal of laparoscope, an average of 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 20193 Aug 2021

First posted17 Jul 2019
Study start30 Oct 2019
Primary completion3 Aug 2021
Study completion3 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hernia Abdominal WallStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04022733
Sponsor's protocol ID: AJIRB-MED-THE-19-056
Status last verified: Nov 2023
First submitted: 15 Jul 2019
Last updated: 9 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hernia Abdominal Wall trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized Study to Compare the Remifentanil Requirements in Deep Versus Moderate Neuromuscular Blocks During the Surgical Pleth Index-guided Analgesia in Patients Undergoing General Anesthesia for Laparoscopic Herniorrhaphy
ClinicalTrials.gov ID: NCT04022733
Acronym / sponsor ID: AJIRB-MED-THE-19-056
Conditions: Hernia Abdominal Wall
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Ajou University School of MedicineUniversity, hospital or other
Study start: 30 Oct 2019 (actual)
Primary completion: 3 Aug 2021 (actual)
Study completion: 3 Aug 2021 (actual)
First posted: 17 Jul 2019 (actual)
Results: Posted 15 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Moderate NMB group	Placebo comparator	Drug: Moderate neuromuscular block
Deep NMB group	Experimental	Drug: Deep neuromuscular block

Who may qualify

Ages: 19 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

laparoscopic hernia repair

Key exclusion criteria (1 listed)

patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease

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
Moderate neuromuscular blockmaintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg	Drug	Moderate NMB group
Deep neuromuscular blockmaintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight	Drug	Deep NMB group

Primary outcome

Remifentanil Infusion Rate
Time frame: from pneumoperitoneum to removal of laparoscope, an average of 30 minutes
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50

Results and safety

Results posted to the registry on 15 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moderate NMB Group	67	64
Deep NMB Group	67	64

Primary outcome: Remifentanil Infusion Rate

Time frame: from pneumoperitoneum to removal of laparoscope, an average of 30 minutes. Mean (Inter-Quartile Range). Unit: µg/kg/min

Measure	Moderate NMB Group n = 64	Deep NMB Group n = 64
Value	0.103 (0.075 to 0.143)	0.073 (0.056 to 0.097)

Adverse events

Time frame: from the start of anesthesia induction until discharge of post-anesthesia care unit, an average of 130 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate NMB Group	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Deep NMB Group	0 of 67 (0%)	0 of 67 (0%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hernia Abdominal Wall

Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Moderate neuromuscular block and Deep neuromuscular block in people with Hernia Abdominal Wall, run by Ajou University School of Medicine at 1 site in South Korea.

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 1 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 9 Nov 2023. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 15 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Remifentanil Infusion Rate (time frame: from pneumoperitoneum to removal of laparoscope, an average of 30 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 NCT04022733.

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 9 Nov 2023.