Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05068037 |
| Other study ID # |
20200114 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
August 31, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
University Medical Centre Ljubljana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
