Influence of Hypnoacupuncture on Early Perioperative Recovery

NCT05068037 | Completed

• 1 other identifier: 20200114
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative stress is associated with various influences before and after surgery. Instead of benzodiazepines, patients can be calmed by non-pharmacological methods. One of these is perioperative medical hypnosis, which has also other beneficial effects such as lower opioid consumption, better wound healing, shorter hospital stays. Acupuncture is used for analgesia. Is is effective for preventing and treating nausea and vomiting. Hypothesis of the study is that perioperative acupuncture reduces the consumption of analgesics and anaesthetics during surgery. The investigators will also study the impact of acupuncture on postoperative nausea and vomiting and analgesic consumption in the postoperative recovery unit and the occurrence of postoperative delirium.

Conditions

Postoperative Nausea and Vomiting; Acute Postoperative Pain

Keywords

MEDICAL HYPNOSIS; PERIOPERATIVE ACUPUNCTURE

Outcome Measures

Primary Outcomes (1)

• Postoperative consumption of antiemetics in mg

  Postoperative nausea and vomiting will be measured in mg of antiemetics in PACU

  24 hours

Secondary Outcomes (2)

• Postoperative consumption of analgesics in mg

  24 hours

• Degree of satisfaction

  24 hours

Study Arms (3)

STANDARD

ACTIVE COMPARATOR

TCI anaesthesia with remifentanil (4-6 µg / ml) and propofol (4-6 µg / ml) Patients will receive an antiemetic (ondansetron 4 mg). The depth of anesthesia will be adjusted to maintain BIS values of 40-55. The remifentanil infusion will be adjusted according to the pain monitor values. Analgesia: piritramide 0.1 mg / kg and metamizole 2.5 g. PACU: Analgesia in VAS\> 3: piritramide 3 mg p.p. Antiemetic for POSB: metoclopramide 10 mg

Other: ANTIEMETICS

CONTROL

ACTIVE COMPARATOR

TCI anaesthesia with remifentanil (4-6 µg / ml) and propofol (4-6 µg / ml) Group does not receive neither acupuncture nor antiemetics. The depth of anesthesia will be adjusted to maintain BIS values of 40-55. The remifentanil infusion will be adjusted according to the pain monitor values. Analgesia: piritramide 0.1 mg / kg and metamizole 2.5 g. PACU: Analgesia in VAS\> 3: piritramide 3 mg p.p. Antiemetic for POSB: ondansetron 4 mg.

Other: NOTHING

STUDY

ACTIVE COMPARATOR

Before surgery, one of the team members will talk to the patient and perform brief medical hypnosis to gain the patient's confidence in the method and teach him the method of relaxing and building an imaginary safe place where he feels comfortable and safe. Therapeutic communication through hypnosis will be used as an additional method in order to improve the well-being and comfort of the patient, reduce stress and use sedatives. TCI anaesthesia with remifentanil (4-6 µg / ml) and propofol (4-6 µg / ml) Patients will receive acupuncture (PC6 and LI4 bilaterally) and no antiemetic The depth of anesthesia will be adjusted to maintain BIS values of 40-55. The remifentanil infusion will be adjusted according to the pain monitor values. Analgesia: piritramide 0.1 mg / kg and metamizole 2.5 g. Removal of acupuncture needles at the end of operation PACU: Analgesia in VAS\> 3: piritramide 3 mg p.p. Antiemetic for POSB: ondansetron 4 mg

Other: ACUPUNCTURE

Interventions

ACUPUNCTURE OTHER

standard acupuncture TCM (analgesia, vomiting)

STUDY

ANTIEMETICS OTHER

NO ACUPUNCTURE, WITH ANTIEMETICS

STANDARD

NOTHING OTHER

NO ACUPUNCTURE, NO ANTIEMETICS

CONTROL

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient consent

You may not qualify if:

• Psychosis
• No consent for the study
• Pregnancy

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Acupuncture Therapy; Antiemetics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents

Study Officials

• JASMINA MARKOVIC BOZIC, MD, PhD

  UMC LJUBLJANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and the outcomes assessor will not know which intervention was used
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; assist. prof., MD, PhD

Model Details: Participants will be randomised to three arms regarding the type of intervention

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: October 5, 2021
• Study Start: May 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)