Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function (HIPPO)
Primary Purpose
Neuromuscular Blockade, Innate Inflammatory Response, Quality of Life
Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Rocuronium Bromide
Rocuronium Bromide
Sponsored by
About this trial
This is an interventional treatment trial for Neuromuscular Blockade
Eligibility Criteria
Inclusion Criteria:
- Age of 18 years or older
- Scheduled for total hip replacement surgery under general anaesthesia
- Informed consent obtained
Exclusion Criteria:
- 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
- Women who are or may be pregnant or currently breastfeeding
- Chronic use of psychotropic drugs
- Use of immunomodulatory medication
Sites / Locations
- RadboudumcRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Deep neuromuscular blockade
Moderate neuromuscular blockade
Arm Description
Participant will receive deep neuromuscular blockade (PTC 1-2)
Participant will receive moderate neuromuscular blockade (TOF 1-2)
Outcomes
Primary Outcome Measures
Quality of Recovery 40 (QoR-40) questionnaire score
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Secondary Outcome Measures
Quality of Recovery 40 (QoR-40) questionnaire score
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Immune function represented by serum cytokine
Serum cytokine IL-6 level
Immune function represented by IL-10
Serum cytokine IL-10 level
Immune function represented by TNF-a
Serum cytokine TNF-a level
Immune function represented by ex-vivo IL-6 production capacity
Ex-vivo IL-6 production capacity upon whole blood Lipopolysaccharide(LPS) stimulation
Immune function represented by ex-vivo IL-10 production capacity
Ex-vivo IL-10 production capacity upon whole blood LPS stimulation
Pain score by numeric pain rating (NRS) scale
pain scores with NRS 0 (no pain) to 10 (severe pain)
Postoperative complications
postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Infectious postoperative complications
Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative
Analgesia consumption
non-cumulative and cumulative opioid use per day in morphine equivalent
Full Information
NCT ID
NCT05562999
First Posted
September 28, 2022
Last Updated
January 8, 2023
Sponsor
Radboud University Medical Center
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05562999
Brief Title
Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function
Acronym
HIPPO
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade, Innate Inflammatory Response, Quality of Life, Postoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep neuromuscular blockade
Arm Type
Experimental
Arm Description
Participant will receive deep neuromuscular blockade (PTC 1-2)
Arm Title
Moderate neuromuscular blockade
Arm Type
Active Comparator
Arm Description
Participant will receive moderate neuromuscular blockade (TOF 1-2)
Intervention Type
Drug
Intervention Name(s)
Rocuronium Bromide
Other Intervention Name(s)
Bridion
Intervention Description
Moderate NMB (TOF 1-2)
Intervention Type
Drug
Intervention Name(s)
Rocuronium Bromide
Other Intervention Name(s)
Bridion
Intervention Description
Deep NMB (PTC 1-2)
Primary Outcome Measure Information:
Title
Quality of Recovery 40 (QoR-40) questionnaire score
Description
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Quality of Recovery 40 (QoR-40) questionnaire score
Description
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Time Frame
Postoperative day 30
Title
Immune function represented by serum cytokine
Description
Serum cytokine IL-6 level
Time Frame
Postoperative day 1
Title
Immune function represented by IL-10
Description
Serum cytokine IL-10 level
Time Frame
Postoperative day 1
Title
Immune function represented by TNF-a
Description
Serum cytokine TNF-a level
Time Frame
Postoperative day 1
Title
Immune function represented by ex-vivo IL-6 production capacity
Description
Ex-vivo IL-6 production capacity upon whole blood Lipopolysaccharide(LPS) stimulation
Time Frame
Postoperative day 1
Title
Immune function represented by ex-vivo IL-10 production capacity
Description
Ex-vivo IL-10 production capacity upon whole blood LPS stimulation
Time Frame
Postoperative day 1
Title
Pain score by numeric pain rating (NRS) scale
Description
pain scores with NRS 0 (no pain) to 10 (severe pain)
Time Frame
During hospital admission up to 3 days postoperative
Title
Postoperative complications
Description
postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Time Frame
30 postoperative days
Title
Infectious postoperative complications
Description
Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative
Time Frame
30 postoperative days
Title
Analgesia consumption
Description
non-cumulative and cumulative opioid use per day in morphine equivalent
Time Frame
During hospital admission up to 3 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 18 years or older
Scheduled for total hip replacement surgery under general anaesthesia
Informed consent obtained
Exclusion Criteria:
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
Women who are or may be pregnant or currently breastfeeding
Chronic use of psychotropic drugs
Use of immunomodulatory medication
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veerle Bijkerk, MD
Phone
0031 24 361 5333
First Name & Middle Initial & Last Name & Degree
Michiel C Warlé, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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
Learn more about this trial
Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function
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