Neuromuscular BlockadePhase 4HIPPONCT05562999
Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function
A Phase 4 study testing Rocuronium Bromide in people with Neuromuscular Blockade and Innate Inflammatory Response, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Monocenter randomized controlled trial to compare the effect of deep neuromuscular blockade (NMB) versus moderate NMB during total hip replacement surgery on postoperative quality of recovery and innate immune function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Innate Inflammatory Response, Quality of Life
- What is being tested?
- Rocuronium Bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Nov 2022to 29 Aug 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Scheduled for total hip replacement surgery under general anaesthesia
- Informed consent obtained
Who cannot join
- Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
- Known or suspected hypersensitivity to rocuronium or sugammadex
- Deficiency of vitamin K dependent clotting factors or coagulopathy
- Severe renal disease (creatinine clearance <30 ml/min), including patients on dialysis
- Severe liver disease (Child-Pugh Classification C)
- Known or suspected neuromuscular disorders impairing neuromuscular function
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- Women who are or may be pregnant or currently breastfeeding
- Chronic use of psychotropic drugs
- Use of immunomodulatory medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Versus Moderate Neuromuscular Blockade During Total HIP Replacement Surgery to Improve POstoperative Quality of Recovery and Immune Function: a Randomized Controlled Study
Monocenter randomized controlled trial to compare the effect of deep neuromuscular blockade (NMB) versus moderate NMB during total hip replacement surgery on postoperative quality of recovery and innate immune function.
Read the detailed description
Rationale: Neuromuscular blockade agents (NMB) may enable surgeons to optimize exposure during hip surgery. With an increasing depth of NMB, manipulation of muscles and adjunctive tissues may be easier, therefore reducing damage to muscles and adjunct tissues. Accumulating evidence exists that the use of deep NMB in laparoscopic surgery is associated with a better quality of recovery and lower pain scores. However, whether this accounts for open surgery is still unknown.
In addition, surgery is associated with postoperative immune suppression. Surgical stress and damage cause the release of Danger Associated Molecular Patterns (DAMPs). After trauma and sepsis, the release of DAMPs is associated with immune paralysis and a higher susceptibility to infectious complications. Previous research indicates that DAMPS are the origin of postoperative immune suppression. The use of deep NMB in hip surgery may reduce surgical damage and thereby lead to a better quality of recovery and secondarily a better preservation of immune cell function.
Primary objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) versus moderate NMB and the quality of recovery after total hip replacement surgery (THR) Secondary objective: To establish the relationship between the use of deep NMB versus moderate NMB and innate immune function after THR surgery
Study design: A monocenter, blinded, randomized controlled clinical trial
Study population: adults who are scheduled for primary or secondary hip replacement surgery under general anaesthesia.
Intervention: Patients will be randomized between a deep NMB (post tetanic count (PTC) 1-2) and moderate NMB (Train-of-four (TOF) 1-2)
Primary endpoint: Quality of Recovery score (QoR-40) at postoperative day 1.
Secondary endpoints: postoperative innate immune function, QoR-40 at postoperative day 30, 30-day postoperative (infectious) complications, postoperative pain scores and opioid consumption
- Conditions
- Neuromuscular Blockade, Innate Inflammatory Response, Quality of Life, Postoperative Complications
- Being tested
- Rocuronium Bromide
- Medical subject headings
- Inflammation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium BromideDrug
Also called Bridion
Moderate NMB (TOF 1-2)
Rocuronium BromideDrug
Also called Bridion
Deep NMB (PTC 1-2)
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular blockade | Experimental | Participant will receive deep neuromuscular blockade (PTC 1-2) Receives: Drug: Rocuronium Bromide |
| Moderate neuromuscular blockade | Active comparator | Participant will receive moderate neuromuscular blockade (TOF 1-2) Receives: Drug: Rocuronium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery 40 (QoR-40) questionnaire score
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Measured: Postoperative day 1
Secondary outcomes (10)
Quality of Recovery 40 (QoR-40) questionnaire score
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Measured: Postoperative day 30
Immune function represented by serum cytokine
Serum cytokine IL-6 level
Measured: Postoperative day 1
Immune function represented by IL-10
Serum cytokine IL-10 level
Measured: Postoperative day 1
Immune function represented by TNF-a
Serum cytokine TNF-a level
Measured: Postoperative day 1
Immune function represented by ex-vivo IL-6 production capacity
Ex-vivo IL-6 production capacity upon whole blood Lipopolysaccharide(LPS) stimulation
Measured: Postoperative day 1
Immune function represented by ex-vivo IL-10 production capacity
Ex-vivo IL-10 production capacity upon whole blood LPS stimulation
Measured: Postoperative day 1
Pain score by numeric pain rating (NRS) scale
pain scores with NRS 0 (no pain) to 10 (severe pain)
Measured: During hospital admission up to 3 days postoperative
Postoperative complications
postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Measured: 30 postoperative days
Infectious postoperative complications
Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative
Measured: 30 postoperative days
Analgesia consumption
non-cumulative and cumulative opioid use per day in morphine equivalent
Measured: During hospital admission up to 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start18 Nov 2022
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Radboud University 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562999
- Sponsor's protocol ID
- NL81931.091.22
- Acronym
- HIPPO
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be analyzed for publication. After that it belongs to Radboud umc where other researchers of Radboud umc may or may not include this database to their study. But there will be no active sharing
Publications
Bijkerk V, Jacobs LMC, Rijnen WHC, Keijzer C, Warle MC, Visser J. Deep versus Moderate Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function: A Randomized Controlled Trial. Anesth Analg. 2026 Feb 1;142(2):355-364. doi: 10.1213/ANE.0000000000007639. Epub 2025 Jul 17.
PubMed 40674253Jacobs LMC, Bijkerk V, van Eijk LT, Joosten LAB, Keijzer C, Visser J, Warle MC. The effect of general versus spinal anesthesia on perioperative innate immune function in patients undergoing total hip arthroplasty. BMC Anesthesiol. 2025 Jan 7;25(1):10. doi: 10.1186/s12871-024-02883-1.
PubMed 39773137Bijkerk V, Visser J, Jacobs LMC, Keijzer C, Warle MC. Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study. BMJ Open. 2023 Aug 28;13(8):e073537. doi: 10.1136/bmjopen-2023-073537.
PubMed 37640469
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Versus Moderate Neuromuscular Blockade During Total HIP Replacement Surgery to Improve POstoperative Quality of Recovery and Immune Function: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05562999
- Acronym / sponsor ID
- HIPPO / NL81931.091.22
- Conditions
- Neuromuscular Blockade, Innate Inflammatory Response, Quality of Life, Postoperative Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 3 Oct 2022 (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.
Monocenter randomized controlled trial to compare the effect of deep neuromuscular blockade (NMB) versus moderate NMB during total hip replacement surgery on postoperative quality of recovery and innate immune function.
Detailed description
Rationale: Neuromuscular blockade agents (NMB) may enable surgeons to optimize exposure during hip surgery. With an increasing depth of NMB, manipulation of muscles and adjunctive tissues may be easier, therefore reducing damage to muscles and adjunct tissues. Accumulating evidence exists that the use of deep NMB in laparoscopic surgery is associated with a better quality of recovery and lower pain scores. However, whether this accounts for open surgery is still unknown.
In addition, surgery is associated with postoperative immune suppression. Surgical stress and damage cause the release of Danger Associated Molecular Patterns (DAMPs). After trauma and sepsis, the release of DAMPs is associated with immune paralysis and a higher susceptibility to infectious complications. Previous research indicates that DAMPS are the origin of postoperative immune suppression. The use of deep NMB in hip surgery may reduce surgical damage and thereby lead to a better quality of recovery and secondarily a better preservation of immune cell function.
Primary objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) versus moderate NMB and the quality of recovery after total hip replacement surgery (THR) Secondary objective: To establish the relationship between the use of deep NMB versus moderate NMB and innate immune function after THR surgery
Study design: A monocenter, blinded, randomized controlled clinical trial
Study population: adults who are scheduled for primary or secondary hip replacement surgery under general anaesthesia.
Intervention: Patients will be randomized between a deep NMB (post tetanic count (PTC) 1-2) and moderate NMB (Train-of-four (TOF) 1-2)
Primary endpoint: Quality of Recovery score (QoR-40) at postoperative day 1.
Secondary endpoints: postoperative innate immune function, QoR-40 at postoperative day 30, 30-day postoperative (infectious) complications, postoperative pain scores and opioid consumption
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular blockade | Experimental | Drug: Rocuronium BromideParticipant will receive deep neuromuscular blockade (PTC 1-2) |
| Moderate neuromuscular blockade | Active comparator | Drug: Rocuronium BromideParticipant will receive moderate neuromuscular blockade (TOF 1-2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years or older
- Scheduled for total hip replacement surgery under general anaesthesia
- Informed consent obtained
Key exclusion criteria (9 listed)
- Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
- Known or suspected hypersensitivity to rocuronium or sugammadex
- Deficiency of vitamin K dependent clotting factors or coagulopathy
- Severe renal disease (creatinine clearance <30 ml/min), including patients on dialysis
- Severe liver disease (Child-Pugh Classification C)
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 |
|---|---|---|
| Rocuronium BromideAlso: BridionModerate NMB (TOF 1-2) | Drug | Moderate neuromuscular blockade |
| Rocuronium BromideAlso: BridionDeep NMB (PTC 1-2) | Drug | Deep neuromuscular blockade |
Primary outcome
Quality of Recovery 40 (QoR-40) questionnaire score
Time frame: Postoperative day 1
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
10 secondary outcomes
Quality of Recovery 40 (QoR-40) questionnaire score
Time frame: Postoperative day 30
Immune function represented by serum cytokine
Time frame: Postoperative day 1
Immune function represented by IL-10
Time frame: Postoperative day 1
Immune function represented by TNF-a
Time frame: Postoperative day 1
Immune function represented by ex-vivo IL-6 production capacity
Time frame: Postoperative day 1
Immune function represented by ex-vivo IL-10 production capacity
Time frame: Postoperative day 1
Pain score by numeric pain rating (NRS) scale
Time frame: During hospital admission up to 3 days postoperative
Postoperative complications
Time frame: 30 postoperative days
Infectious postoperative complications
Time frame: 30 postoperative days
Analgesia consumption
Time frame: During hospital admission up to 3 days postoperative
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 19 Sep 2024.
- Derived from this study: PubMed 40674253Bijkerk V, Jacobs LMC, Rijnen WHC, Keijzer C, Warle MC, Visser J. Deep versus Moderate Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function: A Randomized Controlled Trial. Anesth Analg. 2026 Feb 1;142(2):355-364. doi: 10.1213/ANE.0000000000007639. Epub 2025 Jul 17.
- Derived from this study: PubMed 39773137Jacobs LMC, Bijkerk V, van Eijk LT, Joosten LAB, Keijzer C, Visser J, Warle MC. The effect of general versus spinal anesthesia on perioperative innate immune function in patients undergoing total hip arthroplasty. BMC Anesthesiol. 2025 Jan 7;25(1):10. doi: 10.1186/s12871-024-02883-1.
- Derived from this study: PubMed 37640469Bijkerk V, Visser J, Jacobs LMC, Keijzer C, Warle MC. Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study. BMJ Open. 2023 Aug 28;13(8):e073537. doi: 10.1136/bmjopen-2023-073537.
- Individual participant dataSharing planned: No. All data will be analyzed for publication. After that it belongs to Radboud umc where other researchers of Radboud umc may or may not include this database to their study. But there will be no active sharing
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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 Phase 4 study testing Rocuronium Bromide in people with Neuromuscular Blockade and Innate Inflammatory Response, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 9 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 19 Sep 2024. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Recovery 40 (QoR-40) questionnaire score (time frame: Postoperative day 1). 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 NCT05562999, which also lists 3 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 19 Sep 2024.