Clinical Trials Logo
  1. Home
  2. Major Abdominal Surgery
  3. NCT03166644

Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery — PHOENIX  

Major Abdominal Surgery Clinical Trial

Official title:
Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Feasibility Trial.

Clinical Trial Summary

To determine whether a treatment strategy targeting an individualized sufentanil administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of sufentanil during major abdominal surgery, as compared with standard practice.

Clinical Trial Description

Postoperative respiratory complications are the second most frequent complications after surgery, and a major burden in health care. Postoperative hypoxemia, which is one of the most meaningful factors associated with poor patient outcomes, is common after general anesthesia with rates as high as 30-50% in patients after abdominal surgery, even among those undergoing uneventful procedures. Risk factors for early postoperative hypoxemia, whether modifiable or not, are mainly related to the patient condition, the surgical procedure and the intraoperative anesthesia management strategy, especially the detrimental effects resulting from potential residual effects of anesthetic agents. There is, to date, only limited data on the incidence of postoperative hypoxemia resulting from excessive intraoperative opioid administration. The Analgesia Nociception Index (ANI) is a unit-less index ranging from 0 to 100 calculated from the instantaneous wavelet transform analysis of heart rate variability, which indirectly reflects the parasympathetic tone, with higher ANI values indicating a prominent parasympathetic tone. ANI is sensitive to nociception stimuli and has recently been proposed to evaluate the analgesia/nociception equilibrium. The few interventional studies that have investigated the ability of a protocol-driven intraoperative analgesia procedure to reduce postoperative pain have used mixed results. One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates. In addition, to our knowledge, no study has investigated whether ANI monitoring can be used to improve postoperative outcome. Accordingly, to determine the impact of an ANI-guided individualized opioids administration on postoperative outcomes, a large multicenter randomized controlled trial is needed. However, before such a trial can take place, it is necessary to determine the feasibility in potential participating sites of successfully reducing intraoperative opioid consumption while reducing postoperative pain. The purpose of this study was to examine the feasibility of undertaking such a trial. Our primary hypothesis is that individualizing sufentanil administration to target ANI values between 50 and 70 during major abdominal surgery could reduce the intraoperative dose of sufentanil, as compared with standard practice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03166644
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact
Status Completed
Phase N/A
Start date July 4, 2017
Completion date January 20, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT01194492 - Albumin Kinetics in Generalized Inflammation Phase 4
Completed NCT00512213 - Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery N/A
Completed NCT04798040 - Effects of Lavender Aromatherapy and Cold Application on Pain During Drain Removal N/A
Completed NCT06456918 - ValidationTurkishVersionQualityofRecovery-15
Completed NCT02337010 - Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management N/A
Completed NCT00549419 - Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery Phase 4
Completed NCT04080479 - Bolus Versus Continuous Enteral Tube Feeding N/A
Recruiting NCT03295851 - Preoperative Intravenous Iron Infusion to Reduce Post-surgical Complications: a Pilot Randomised Control Trial Phase 4
Withdrawn NCT01403909 - Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery N/A
Recruiting NCT02534012 - Paravertebral Block vs. General Anesthesia for Major Abdominal Surgery N/A
Completed NCT05365113 - Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients N/A
Recruiting NCT05276596 - Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction N/A
Completed NCT01075646 - Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery Phase 4
Completed NCT04935814 - Cardiac Output Response to Vasopressin Infusion In Abdominal Surgery Patients Under Mechanical Ventilation Phase 4
Completed NCT04345354 - Observational Study of the Value of Using Obstructive Sleep Apnea-hypopnea Syndrome (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.
Recruiting NCT06285526 - Glycocalyx Monitoring in Major Abdominal Surgery
Completed NCT04480775 - Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block Phase 2/Phase 3
Completed NCT05795608 - Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery N/A
Completed NCT02142816 - Fluid Requirement During Surgery PVI v Doppler N/A
Completed NCT01217151 - Perioperative Hemodynamic Optimization Using the NICOM Device N/A