Influence of Hypnoacupuncture on Early Perioperative Recovery
Condition: Postoperative Nausea and Vomiting; Acute Postoperative Pain
MeSH terms: Pain, Postoperative; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

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.
    

Intervention name(s): ACUPUNCTURE; ANTIEMETICS; NOTHING
Intervention type(s): Other; Other; Other
Intervention description(s): standard acupuncture TCM (analgesia, vomiting); NO ACUPUNCTURE, WITH ANTIEMETICS; NO ACUPUNCTURE, NO ANTIEMETICS
Intervention MeSH terms: Antiemetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised to three arms regarding the type of intervention
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: MEDICAL HYPNOSIS; PERIOPERATIVE ACUPUNCTURE