Influence of Hypnoacupuncture on Early Perioperative Recovery

NCT ID: NCT05068037

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-08-31

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.

Detailed Description

Detailed Description: Perioperative stress is associated with the procedure itself, anaesthesia, as well as various influences before and after surgery. Patient's feeling of discomfort and anxiety in the preoperative period are treated with benzodiazepines. Although these drugs calm the patient, they are associated with the occurrence of postoperative delirium, especially in elderly patients. Instead of benzodiazepines, patients can be calmed by other non-pharmacological methods. One of these is perioperative medical hypnosis, which also has other beneficial effects such as lower opioid consumption, better wound healing, shorter hospital stays.

At the Clinical Department of Anesthesiology and Intensive Care at the University Medical Center Ljubljana, in cooperation with the Clinical Department of Neurosurgery, investigators have been routinely using perioperative medical hypnosis in awake brain surgeries since 2016 and have very good experience.

The risk of postoperative delirium is also reduced by the use of intravenous anesthesia and reduced use of opioids.

Acupuncture has been a recognized and well-established method for the treatment of acute and chronic pain by the WHO for several decades. With the right choice of points, in addition to treating pain, we can also reduce nausea and vomiting. It is a safe method in the hands of trained doctors, with virtually no side effects.

Perioperative acupuncture has a number of beneficial effects: it reduces the consumption of anesthetics and analgesics, reduces the number of perioperative complications, and protects vital organs.

With the research, investigators want to determine if acupuncture reduces the consumption of analgesics and anaesthetics during surgery. The investigators will study also the impact of acupuncture on nausea, vomiting and analgesic consumption in the postoperative recovery unit and the occurrence of postoperative delirium.

The additional value of the research will be monitoring the quality of postoperative recovery both in terms of drug consumption and recording of postoperative complications, as well as in terms of patient satisfaction and well-being.

Prevention of perioperative complications, improved quality of patient recovery and the implementation of complementary medicine methods are among the important challenges of modern, evidence-based medicine.

The prospective randomised study will include surgical patients older than 18 years, classified by the American Society of Anesthesiologists (ASA) in groups I-III, who will be scheduled for minor surgery under general anaesthesia (inguinal hernia, spine, minor plastic surgery). Patients will sign the consent for the procedure, anaesthesia and participation in the research.

Pregnant women, psychiatric patients, children, and patients who will not sign the consent or will not be capable to cooperate in the study will not be included..

Included surgeries are not a risk factor for increased nausea and vomiting. In the study group one of the team members will talk to the patient before the surgery and perform brief medical hypnosis to improve the patient's well-being and comfort.

Therefore the patient will be under less stress in the perioperative period. Prior to initiating anesthesia, patients will be randomized into three groups: patients with hypnosis and acupuncture (study), patients with antiemetic therapy (standard), patients without antiemetic and acupuncture therapy (control).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. Patients will receive analgesia according to the protocol. Investigators will collect pain and POSB data in the postoperative recovery unit and in the ward after 24 hours.

Duration of surgery and anaesthesia and the consumption of analgesics and anaesthetics will be recorded.

After three days, patients will be asked about their well-being and satisfaction.

The research will be performed by specialist anesthesiologists and an anesthesiology specialist who are trained in the pharmacological and non-pharmacological skills required for the research.

Conditions

Postoperative Nausea and Vomiting; Acute Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

STANDARD

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

Group Type: ACTIVE_COMPARATOR

ANTIEMETICS

Intervention Type: OTHER

NO ACUPUNCTURE, WITH ANTIEMETICS

CONTROL

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.

Group Type: ACTIVE_COMPARATOR

NOTHING

Intervention Type: OTHER

NO ACUPUNCTURE, NO ANTIEMETICS

STUDY

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

Group Type: ACTIVE_COMPARATOR

ACUPUNCTURE

Intervention Type: OTHER

standard acupuncture TCM (analgesia, vomiting)

Interventions

ACUPUNCTURE

standard acupuncture TCM (analgesia, vomiting)

Intervention Type: OTHER

ANTIEMETICS

NO ACUPUNCTURE, WITH ANTIEMETICS

Intervention Type: OTHER

NOTHING

NO ACUPUNCTURE, NO ANTIEMETICS

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-Patient consent

Exclusion Criteria

• Psychosis
• No consent for the study
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Jasmina Markovic Bozic

Principal Investigator; assist. prof., MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JASMINA MARKOVIC BOZIC, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC LJUBLJANA

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

20200114

Identifier Type: -

Identifier Source: org_study_id