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Postoperative Nausea and VomitingNCT05068037

Influence of Hypnoacupuncture on Early Perioperative Recovery

A study testing ACUPUNCTURE, ANTIEMETICS and NOTHING in people with Postoperative Nausea and Vomiting and Acute Postoperative Pain, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
ACUPUNCTURE, ANTIEMETICS and NOTHING
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSlovenia
Study dates
1 May 2021to 31 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Patient consent

Who cannot join

  • Psychosis
  • No consent for the study
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Slovenia1 site
  • University Medical Centre Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Influence of Perioperative Medical Hypnosis and Acupuncture on Early Postoperative Recovery

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.

Being tested
ACUPUNCTURE, ANTIEMETICS, NOTHING
Keywords
MEDICAL HYPNOSIS, PERIOPERATIVE ACUPUNCTURE
Medical subject headings
Postoperative Nausea and Vomiting, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACUPUNCTUREOther

    standard acupuncture TCM (analgesia, vomiting)

  • ANTIEMETICSOther

    NO ACUPUNCTURE, WITH ANTIEMETICS

  • NOTHINGOther

    NO ACUPUNCTURE, NO ANTIEMETICS

Study groups in NCT05068037
Study groupRoleWhat they receive
STANDARDActive comparatorTCI 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
Receives: Other: ANTIEMETICS
CONTROLActive comparatorTCI 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.
Receives: Other: NOTHING
STUDYActive comparatorBefore 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
Receives: Other: ACUPUNCTURE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative consumption of antiemetics in mg

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

    Measured: 24 hours

Secondary outcomes (2)
  1. Postoperative consumption of analgesics in mg

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

    Measured: 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

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start1 May 2021
  3. Primary completion31 Aug 2022
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomised to three arms regarding the type of intervention
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05068037
Sponsor's protocol ID
20200114
Status last verified
Nov 2022
First submitted
3 Jun 2021
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ACUPUNCTURE, ANTIEMETICS and NOTHING in people with Postoperative Nausea and Vomiting and Acute Postoperative Pain, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative consumption of antiemetics in mg (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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