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CompletedNCT05068037Updated Nov 8, 2022

Influence of Hypnoacupuncture on Early Perioperative Recovery

An interventional study of ACUPUNCTURE and ANTIEMETICS in Postoperative Nausea and Vomiting and Acute Postoperative Pain, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Nausea and Vomiting
  • Acute Postoperative Pain

Keywords

  • MEDICAL HYPNOSIS
  • PERIOPERATIVE ACUPUNCTURE
03

In context

Postoperative Nausea and Vomiting

629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.

This study's enrollment of 60 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 294 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-Patient consent

Exclusion criteria

Exclusion Criteria:

  • Psychosis
  • No consent for the study
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    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

    Other: ANTIEMETICS

  • Active comparator
    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.

    Other: NOTHING

  • Active comparator
    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

    Other: ACUPUNCTURE

Interventions

  • OtherACUPUNCTURE

    standard acupuncture TCM (analgesia, vomiting)

  • OtherANTIEMETICS

    NO ACUPUNCTURE, WITH ANTIEMETICS

  • OtherNOTHING

    NO ACUPUNCTURE, NO ANTIEMETICS

06

What researchers measure

Primary outcomes

  1. Postoperative consumption of antiemetics in mg

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

    Time frame: 24 hours

Secondary outcomes

  1. Postoperative consumption of analgesics in mg

    Postoperative pain will be measured in mg of consumed analgetics in PACU

    Time frame: 24 hours

  2. Degree of satisfaction

    Patient satisfaction will be measured in scale from 0-5, where 0 means not satisfied and 5 means very satisfied

    Time frame: 24 hours

07

Study locations

1 site
  • University Medical Centre Ljubljana
    Ljubljana, 1000, Slovenia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05068037
Responsible party
Jasmina Markovic Bozic (Principal Investigator; assist. prof., MD, PhD, University Medical Centre Ljubljana) — Principal investigator
First posted
Oct 5, 2021
Start date
May 1, 2021
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Nov 8, 2022

Study contacts

JASMINA MARKOVIC BOZIC, MD, PhD
principal investigator · UMC LJUBLJANA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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