Deep versus moderate neuromuscular blockade during total HIP replacement surgery to improve POstoperative quality of recovery and immune function: a randomized controlled study

Deep versus moderate neuromuscular blockade during total HIP replacement surgery to improve POstoperative quality of recovery and immune function: a randomized controlled study - HIPPO study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002451-19-NL

Enrollment

100

Registered

2022-07-20

Start date

2022-09-22

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip osteoarthritis

Interventions

Trade Name: Rocuronium Product Name: Rocuronium Pharmaceutical Form: Solution for injection Trade Name: Rocuronium Product Name: Rocuronium Pharmaceutical Form: Solution for injection Trade Name: Su

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age of 18 years or older - Scheduled for total hip replacement surgery under general anaesthesia - Informed consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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 liver- or renal disease (including patients on dialysis) - Known or suspected neuromuscular disorders impairing neuromuscular function - Women who are or may be pregnant or currently breastfeeding - Chronic use of psychotropic drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall objective of this study is to translate the beneficial impact of deep neuromuscular blockade versus moderate neuromuscular blockade on clinical outcomes (i.e. quality-of-recovery and pain), as observed in patients undergoing different types if laparoscopic surgeries to patients undergoing open surgical procedures. Specified the main objective of this study is to assess the potential effect of deep neuromuscular blockade on the quality of recovery after total hip replacement surgery under general anesthesia. ;Secondary Objective: - To establish the relationship between the use of deep neuromuscular blockade versus moderate deep neuromuscular blockade and innate immune function after total hip replacement surgery. - To establish the relationship between the use of deep neuromuscular blockade versus moderate deep neuromuscular blockade and postoperative pain scores and the incidence infectious complications after total hip replacement surgery. ;Primary end point(s): The primary outcome is the quality of recovery at postoperative day 1 measured bij the quality-of-recovery 40 questionnaire ;Timepoint(s) of evaluation of this end point: Postoperative day 1	—

Measure

Time frame

Main Objective: The overall objective of this study is to translate the beneficial impact of deep neuromuscular blockade versus moderate neuromuscular blockade on clinical outcomes (i.e. quality-of-recovery and pain), as observed in patients undergoing different types if laparoscopic surgeries to patients undergoing open surgical procedures. Specified the main objective of this study is to assess the potential effect of deep neuromuscular blockade on the quality of recovery after total hip replacement surgery under general anesthesia. ;Secondary Objective: - To establish the relationship between the use of deep neuromuscular blockade versus moderate deep neuromuscular blockade and innate immune function after total hip replacement surgery. - To establish the relationship between the use of deep neuromuscular blockade versus moderate deep neuromuscular blockade and postoperative pain scores and the incidence infectious complications after total hip replacement surgery. ;Primary end point(s): The primary outcome is the quality of recovery at postoperative day 1 measured bij the quality-of-recovery 40 questionnaire ;Timepoint(s) of evaluation of this end point: Postoperative day 1

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Secondary

Measure	Time frame
Secondary end point(s): The secondary outcomes of the study are: -Postoperative innate immune function measured by: serum cytokine levels (TNF-a, IL-6 and IL-10) and ex-vivo cytokine production capacity upon whole blood lipopolysaccharide (LPS) stimulation at the end of surgery and at postoperative day 1. - Pain scores (NRS 0-10) and total analgesia consumption at the post anesthesia care unit(PACU) and postoperative day 1 -40-day postoperative (infectious) complications scored according to the relevant endpoint of the StEP-COMPAC group initiative and by the Clavien Dindo classification -Likert scale scores for surgical workings conditions and assessment stability hip prosthesis;Timepoint(s) of evaluation of this end point: - End of surgery - At the post anesthesia care unit direct after surgery - Postoperative day 1 - Postoperative day 40	—

Measure

Time frame

Secondary end point(s): The secondary outcomes of the study are: -Postoperative innate immune function measured by: serum cytokine levels (TNF-a, IL-6 and IL-10) and ex-vivo cytokine production capacity upon whole blood lipopolysaccharide (LPS) stimulation at the end of surgery and at postoperative day 1. - Pain scores (NRS 0-10) and total analgesia consumption at the post anesthesia care unit(PACU) and postoperative day 1 -40-day postoperative (infectious) complications scored according to the relevant endpoint of the StEP-COMPAC group initiative and by the Clavien Dindo classification -Likert scale scores for surgical workings conditions and assessment stability hip prosthesis;Timepoint(s) of evaluation of this end point: - End of surgery - At the post anesthesia care unit direct after surgery - Postoperative day 1 - Postoperative day 40

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Countries

Netherlands

Contacts

Public ContactVascular surgery

Radboudumc

veerle.bijkerk@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026