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The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT05302128
Recruitment Status : Not yet recruiting
First Posted : March 31, 2022
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
Atlas University
Information provided by (Responsible Party):
Dr. Özlem İbrahimoğlu, Istanbul Medeniyet University

Study Description
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Brief Summary:
Postoperative nausea and vomiting (PONV) was defined by the American Society of PeriAnesthesia Nurses (ASPAN) as nausea and/or vomiting in the first 24 hours after surgery and is among the most common complications after pain in patients undergoing surgery. PONV is divided into three as early, late, and delayed. Nausea-vomiting developing within 2-6 hours after surgery is classified as early, nausea-vomiting developing within 6-24 hours after surgery is classified as delayed, and nausea and/or vomiting developing within the first 24 hours after surgery are classified as delayed PONV. PONV increases the length of stay in the recovery room, delays starting oral intake, causes fluid and electrolyte imbalance, and causes pain, dehydration, delayed wound healing, decreased patient comfort, prolonged hospitalization, and increased cost. Therefore, the prevention and management of nausea and vomiting in the perioperative period in surgical patients are very important.

Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Postoperative Nausea Postoperative Vomiting Other: Cold vapor Not Applicable

Detailed Description:

Postoperative nausea and vomiting (PONV) was defined by the American Society of PeriAnesthesia Nurses (ASPAN) as nausea and/or vomiting in the first 24 hours after surgery and is among the most common complications after pain in patients undergoing surgery. PONV increases the length of stay in the recovery room, delays starting oral intake, causes fluid and electrolyte imbalance, and causes pain, dehydration, delayed wound healing, decreased patient comfort, prolonged hospitalization, and increased cost. Therefore, the prevention and management of nausea and vomiting in the perioperative period in surgical patients are very important.

In a meta-analysis study that included data from eleven countries, the prevalence of PONV was 27.7%, the prevalence of postoperative nausea was 31.4% and the prevalence of post-operative vomiting was 16.8%. In a study conducted in Turkey, it was reported that 45.9% of surgical patients had nausea and 23.6% had vomiting in the postoperative period. In another study conducted in the postoperative recovery unit, it was reported that 29% of the patients experienced nausea and vomiting.

The risk of PONV may vary depending on the patient, anesthesia, and surgical intervention. Patient-related risk factors include female gender, young age (under 50 years of age), obesity, history of motion sickness; anesthesia-related risk factors include the type of anesthesia, duration of administration, use of volatile anesthetics, opioids, and nitrous oxide; Among the risk factors for previous surgical interventions are laparoscopic, bariatric, gynecological and cholecystectomy surgeries.

Pharmacological treatment, non-pharmacological treatment methods, or both are used in the management of PONV in patients undergoing surgical intervention. Today, a multimodal approach is recommended in the management of PONV in early recovery protocols in surgical patients. Antiemetic drugs used among pharmacological methods can cause side effects such as headache, constipation, drowsiness, tremor, irregular heartbeat, and wound infection. Therefore, non-pharmacological treatment methods have an important place in care practices. In the literature, there are many studies on the successful application of non-pharmacological treatment methods such as massage, progressive relaxation exercises, hypnosis, acupuncture, yoga, acupressure, transcutaneous electrical nerve stimulation, music therapy, herbal treatments, and aromatherapy in the prevention of PONV.

The cold application creates vasoconstriction in the vessels in the area where it is applied, decreases the metabolic rate, and reduces edema. The cold application reduces muscle temperature by reducing the tension sensitivity of muscle spindles with the reflex effect of heat receptors or inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. Temperature can affect the release of odorous volatile substances in drugs. The cold application also has clinically important potential effects on nausea caused by unpleasant tastes by reducing the olfactory component of negative aromas. Cold can be applied in different ways. One of them is administration by inhalation. In the literature, there are studies on the positive effects of cold vapor application on sore throat, cough, swallowing, and hoarseness. In a study, it was determined that postoperative nausea and vomiting were less in patients who received oral care with the cold application after laparoscopic myomectomy compared to the control group. There is no study in the literature examining the effect of cold vapor application on PONV.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients who were hospitalized for laparoscopic cholecystectomy and met the sample selection criteria will be included in the experimental and control groups by block randomization method using the random numbers table on the computer.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy
Estimated Study Start Date : April 11, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cold vapor group
Cold vapor will be applied to the experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtime-un600aultrasonik-nebulizator/). The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5 (1-10), air blowing intensity 5 (1-10), heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th, 12th, and 24th hours after the cold vapor application in the postoperative service.
 Other: Cold vapor
Before surgery, the socio-demographic data of the patients will be recorded. After surgery, patients will be evaluated in the recovery room for their suitability to participate in the study with the Ramsay sedation scale and the Modified Aldrete Scale. Cold vapor will be applied to the patients for 15 minutes in the recovery room during the postoperative period. The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5, air blowing intensity 5, heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th,12th, and 24th hours after the cold vapor application in the postoperative service.
No Intervention: Control group
Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of nausea and vomiting when they come to the recovery room and at the 2nd, 6th,12th, and 24th hours after the surgery in the postoperative service.


Outcome Measures
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Primary Outcome Measures :
  1. Cold vapor [ Time Frame: First 24 hours after surgery ]
    The Visual Analogue Scale (VAS) of the patients for nausea who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.

  2. Cold vapor [ Time Frame: First 24 hours after surgery ]
    The Postoperative Nausea and Vomiting Impact Scale of the patients for nausea and vomiting who underwent cold vapor are decreased compared to those who do not. A score between 0 and 6 is taken from the Postoperative Nausea and Vomiting Impact Scale. It is good that the score from the Postoperative Nausea and Vomiting Impact Scale has decreased.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being 18 years or older
  • To undergo laparoscopic cholecystectomy
  • Having an ASA score of 1-2
  • Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room.
  • Having a Modified Aldrete score of at least 9 in the postoperative recovery room
  • To be willing to participate in the study.

Exclusion Criteria:

  • To undergo emergency surgery
  • Being under the age of 18
  • Having an ASA score of 3 and above
  • Not agreeing to participate in the study.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05302128


Contacts
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Contact: Özlem İbrahimoğlu, PhD +905436195971 oogutlu@gmail.com
Contact: Betül Güven, PhD +905325283751 betulguwen@hotmail.com

Sponsors and Collaborators
Istanbul Medeniyet University
Atlas University
More Information
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Additional Information:

Publications:

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Responsible Party: Dr. Özlem İbrahimoğlu, Assisstant Professor, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT05302128    
Other Study ID Numbers: IstanbulMU12
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A decision will be made after consultation with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Özlem İbrahimoğlu, Istanbul Medeniyet University:
Nausea
Vomiting
Nursing care
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
 Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes