HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia

Anesthesia Clinical Trial

— HYSTERIA  

Official title:

Prospective Randomized Study Evaluating the Effect of Pre-operative Hypnosis on Anesthesia, Analgesia and Perioperative Stress Laparoscopic Ileo-caecal Resections of Crohn's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261414
• Other study ID #: 2013_54
• Secondary ID: 2014-A00622-45
• Status: Completed
• Phase: N/A
• Start date: May 27, 2015
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study will be to show a decrease in postoperative morphine consumption by the practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal resection for Crohn's disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being affected by a crohn's disease, reaching the small intestine (ileal or ileo-colic) and requiring ileo-caecal resection by laparoscopy

• Never been operated for abdominal crohn's disease

Exclusion Criteria:

• Pregnant women

• A history of intestinal resection for crohn's disease

• Emergency surgery

• Corticotherapy in progress

• Deaf patients

• non-Francophone Patients

• Patients with knowledge of self-hypnosis

Related Conditions & MeSH terms

• Anesthesia
• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Procedure:
• Hypnosis
A short preanesthetic hypnosis before induction of anesthesia
• usual care
Standard care before induction of anesthesia

Locations

Country	Name	City	State
France	Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record	During the first 24 postoperative hours
Secondary	Total morphine consumption	Compare the cumulative morphine consumption between the 24 and the 48 postoperative hours Data from PCA pump and patient medical record	between the 24 and the 48 postoperative hours
Secondary	Total number of patients with complications		during first 7 postoperative days
Secondary	Intraoperative consumption of hypnotics and opioids	The hypnotics and opioids drug dose will be recorded	during first 7 postoperative days
Secondary	Antiemetics consumption	The antiemetic drug dose will be recorded	during first 7 postoperative days
Secondary	Postoperative nausea and vomiting (PONV) Score	PONV risk assessment tool Based on apfel's simplified risk score	first 24 postoperative hours
Secondary	Duration of hospital stay		during first 7 postoperative days
Secondary	Time physiological function recovery	Ability to drink, to eat, to urinate, to walk	during first 7 postoperative days