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.
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
- Conditions the study is for
- Postoperative Nausea and Vomiting, Acute Postoperative Pain
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Other: ACUPUNCTURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Postoperative consumption of analgesics in mg
Postoperative pain will be measured in mg of consumed analgetics in PACU
Measured: 24 hours
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.
- First posted5 Oct 2021
- Study start1 May 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasmina Markovic Bozic, University Medical Centre Ljubljana
- Investigators
- JASMINA MARKOVIC BOZIC, MD, PhD, Principal investigator, UMC LJUBLJANA
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Perioperative Medical Hypnosis and Acupuncture on Early Postoperative Recovery
- ClinicalTrials.gov ID
- NCT05068037
- Acronym / sponsor ID
- 20200114
- Keywords
- MEDICAL HYPNOSIS, PERIOPERATIVE ACUPUNCTURE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomised to three arms regarding the type of intervention
| Arm | Type | Receives |
|---|---|---|
| STANDARD | Active comparator | Other: ANTIEMETICSTCI 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 |
| CONTROL | Active comparator | Other: NOTHINGTCI 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. |
| STUDY | Active comparator | Other: ACUPUNCTUREBefore 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patient consent
Key exclusion criteria (3 listed)
- Psychosis
- No consent for the study
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACUPUNCTUREstandard acupuncture TCM (analgesia, vomiting) | Other | STUDY |
| ANTIEMETICSNO ACUPUNCTURE, WITH ANTIEMETICS | Other | STANDARD |
| NOTHINGNO ACUPUNCTURE, NO ANTIEMETICS | Other | CONTROL |
Primary outcome
Postoperative consumption of antiemetics in mg
Time frame: 24 hours
Postoperative nausea and vomiting will be measured in mg of antiemetics in PACU
2 secondary outcomes
Postoperative consumption of analgesics in mg
Time frame: 24 hours
Degree of satisfaction
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JASMINA MARKOVIC BOZIC, MD, PhD principal investigator
UMC LJUBLJANA
1 site in 1 country: see every site and its status.
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.