Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery (TRANSIT)
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|ClinicalTrials.gov Identifier: NCT04433390|
Recruitment Status : Completed
First Posted : June 16, 2020
Last Update Posted : March 8, 2022
Postoperative ileus, defined as the transient postoperative functional inhibition of propulsive bowel activity, commonly occurs in patients after cardiac surgery and contributes to postoperative morbidity.
Naloxegol is a peripheral opioid receptor antagonist. Recent studies showed that naloxegol is effective in the treatment of chronic opioid-induced constipation but there is no data on its use in the management of postoperative ileus after cardiac surgery.
The main objective of this prospective, double-blind, randomized, placebo-controlled trial is to assess the effectiveness of the perioperative use of naloxegol in reducing the duration of the postoperative ileus in patients undergoing cardiac surgery.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Ileus (Post Cardiac Surgery Constipation)||Drug: Naloxegol Drug: inert tablet||Phase 3|
Digestive complications following cardiac surgery, such as paralytic ileus and Ogilvie syndrome, are frequent and worsen the prognosis of patients. They pose a real problem of care in intensive care, inducing morbidity and mortality, extended hospital stay and a significant post-operative cost.
Few treatments are effective to reduce transit recovery time, except the neostigmine which has a serious side effects including cardiac ones.
During cardiac surgery, opioid treatments are frequently used to relieve the pain like sternotomy pain.
The pharmacologic effect of opioid induces the postoperative uleus. Opioid receptors are distributed in the central nervous system, where they are involved in the perception of pain, and in the peripheral nervous system, especially in the mesenteric nervous system, where they regulate intestinal peristalsis.
Morphine receptors antagonist are a target for prevention and treatment of post operative ileus syndrome such as alvimopan and naloxone.
A therapeutic trial demonstrates a decrease in the rate of pneumonia in intensive care patient mechanically ventilated who received naloxone.
Naloxegol is a peripheral antagonist of opioid receptor, from the alvimopan family. It has been designed to antagonize the peripheral, but not central, effects of opioids at therapeutic doses. Naloxegol is a substrate for cytochrome P450 (CYP 3A4). Following oral administration, naloxegol is absorbed rapidly, with peak concentrations achieved at less than 2 hours.
After once daily administration, plasma concentration equilibrium is reached within 2-3 days with minimal accumulation.
The main route of elimination for naloxegol is hepatic. Naloxegol has been shown to be effective in randomized trials of chronic opioid induced constipation, but there is no data on its use in the postoperative ileus.
Research hypothesis: the addition of naloxegol in pre and postoperative cardiac surgery could reduce the time to transit recovery and the rate of digestive and respiratory complications.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||305 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||the nurse giving the treatment is not the outcomes assessor.|
|Official Title:||Time to Transit Recovery After Treatment With Naloxegol in Cardiac Surgery Intensive Care Trial|
|Actual Study Start Date :||October 14, 2020|
|Actual Primary Completion Date :||January 28, 2022|
|Actual Study Completion Date :||March 3, 2022|
Experimental: Naloxegol group
naloxégol tablet by oral route
one naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
Placebo Comparator: Placebo group
inert tablet by oral route
Drug: inert tablet
one inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
- Evaluate the effect of perioperative naloxegol administration on the duration of postoperative ileus after cardiac surgery [ Time Frame: 5 days ]Time (hour) to transit recovery after cardiac surgery
- Incidence of digestive complications [ Time Frame: 30 days ]rate of digestive complications
- Evaluate the effect of the administration of Naloxegol on respiratory complications [ Time Frame: 30 days ]rate of respiratory complications
- Evaluate the effect of the administration of Naloxegol on infectious complications [ Time Frame: 30 days ]rate of infectious complications
- Verify the effectiveness of analgesia [ Time Frame: day 1, day2, day3 ]Pain Visual Analogue Scale (VAS) ranging from 0 to 10 (0=no pain, 10=worst possible pain)
- Compare the length of hospital stay [ Time Frame: 30 days ]Duration of hospital stay (days)
- Compare the length of ICU stay [ Time Frame: 30 days ]Duration of ICU stay (days)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433390
|CMC Ambroise Paré|
|Neuilly-sur-Seine, Neuilly Sur Seine, France, 92200|