The Effects of CO2 Pneumoperitoneum at Different Temperature in Laparoscopic Surgery

NCT04508387 | Completed

• 1 other identifier: EGE19-3.1/40
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: It is recommended to heat and humidify CO2 in laparoscopic surgery to prevent postoperative pain and hypothermia but information about its effects on hemodynamic and respiratory parameters is limited. The investigators aimed to investigate the effects of standard and heated-humidified CO2 on hemodynamic and respiratory parameters. Study design: One hundred patients who underwent laparoscopic hysterectomy for benign pathology were divided into two groups: Group CD (cold-dry) patients were administered standard CO2, while Group HH (heated-humidified) patients were administered 95% humidified insufflation at 37°C. Hemodynamic and respiratory parameters, body temperature, pain score and blood count parameters were recorded.

Conditions

Benign Neoplasm of Cervix Uteri; Gynecological Laparoscopy

Keywords

Gynecological laparoscopy; standard CO2; heated-humidified CO2; hemodynamic parameters; respiratory parameters

Outcome Measures

Primary Outcomes (3)

• hemodynamic parameters: diastolic and mean blood pressure

  diastolic and mean blood pressure

  In the operation period

• body temperature

  body temperature

  In the operation period

• respiratory parameters: tidal volume

  tidal volume

  In the operation period

Secondary Outcomes (2)

• Visual Analogue Scale

  24 hour

• morphine consumption

  24 hour

Study Arms (2)

Group HH (heated-humidified) patients

ACTIVE COMPARATOR

Group HH (heated-humidified) patients were administered 95% humidified CO2 insufflation at 37°C. All patients were given information and training on the anesthesia method, the use of the patient-controlled-analgesia (PCA) device and the visual analog scale (VAS) the day before the operation. The patients' demographic data (age, weight, height, etc.) and their basal systolic, diastolic and mean blood pressures and heart rates were measured prior to the operation and recorded on the case report form.

Procedure: Group HH (heated-humidified)

Group CD (cold-dry) patients

PLACEBO COMPARATOR

Group CD (cold-dry) patients were administered dry CO2 via insufflator at room temperature (21°C). All patients were given information and training on the anesthesia method, the use of the patient-controlled-analgesia (PCA) device and the visual analog scale (VAS) the day before the operation. The patients' demographic data (age, weight, height, etc.) and their basal systolic, diastolic and mean blood pressures and heart rates were measured prior to the operation and recorded on the case report form.

Procedure: Group HH (heated-humidified)

Interventions

Group HH (heated-humidified) PROCEDURE

Group CD patients were administered dry CO2 via insufflator at room temperature (21°C), while Group HH patients were administered 95% humidified CO2 insufflation at 37°C. The study was planned as a randomized and double-blind study, where patients were not informed of their group. During the operation and in the postoperative period, the patients were followed up by two different anesthetists. All patients were given information and training on the anesthesia method, the use of the patient-controlled-analgesia device and the visual analog scale the day before the operation. The patients' demographic data (age, weight, height, etc.) and their basal systolic, diastolic and mean blood pressures and heart rates were measured prior to the operation and recorded on the case report form. Both groups received the standard general anesthesia protocol. Laparoscopic surgery was performed in the same manner for all cases by AA.

Group CD (cold-dry) patients; Group HH (heated-humidified) patients

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II patients aged 40-65 who underwent laparoscopic hysterectomy for benign pathology.

You may not qualify if:

• Patients with chronic obstructive pulmonary disease, asthma, advanced liver and kidney disease, infection, bleeding disorder and drug allergies

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Asuman Sargin

Izmir, Anesthesiology and Reanimation, Ege Uni, 35040, Turkey (Türkiye)

Location

Related Publications (4)

• Scott JE, Singh A, Valverde A, Blois SL, Foster RA, Kilkenny JJ, Linden AZ. Effect of pneumoperitoneum with warmed humidified or standard-temperature carbon dioxide during laparoscopy on core body temperature, cardiorespiratory and thromboelastography variables, systemic inflammation, peritoneal response, and signs of postoperative pain in healthy mature dogs. Am J Vet Res. 2018 Dec;79(12):1321-1334. doi: 10.2460/ajvr.79.12.1321.

  PMID: 30457909 BACKGROUND

• Birch DW, Dang JT, Switzer NJ, Manouchehri N, Shi X, Hadi G, Karmali S. Heated insufflation with or without humidification for laparoscopic abdominal surgery. Cochrane Database Syst Rev. 2016 Oct 19;10(10):CD007821. doi: 10.1002/14651858.CD007821.pub3.

  PMID: 27760282 RESULT

• Cheong JY, Keshava A, Witting P, Young CJ. Effects of Intraoperative Insufflation With Warmed, Humidified CO2 during Abdominal Surgery: A Review. Ann Coloproctol. 2018 Jun;34(3):125-137. doi: 10.3393/ac.2017.09.26. Epub 2018 Jun 30.

  PMID: 29991201 RESULT

• Gunusen I, Akdemir A, Sargin A, Karaman S. The effects of CO2 pneumoperitoneum at different temperature and humidity on hemodynamic and respiratory parameters and postoperative pain in gynecological laparoscopic surgery: A prospective randomized controlled study. Asian J Surg. 2022 Jan;45(1):154-161. doi: 10.1016/j.asjsur.2021.04.005. Epub 2021 Apr 20.

  PMID: 33888367 DERIVED

Study Officials

• Ilkben gunusen, 1

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study was planned as a randomized and double-blind study, where patients were not informed of their group. During the operation and in the postoperative period, the patients were followed up by two different anesthetists.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: The patients were divided into two groups according to a randomization scheme created by a computer: Group CD (cold-dry) patients were administered dry CO2 via insufflator at room temperature (21°C), while Group HH (heated-humidified) patients were administered 95% humidified CO2 insufflation at 37°C. The study was planned as a randomized and double-blind study, where patients were not informed of their group. During the operation and in the postoperative period, the patients were followed up by two different anesthetists. All patients were given information and training on the anesthesia method, the use of the patient-controlled-analgesia (PCA) device and the visual analog scale (VAS) the day before the operation. The patients' demographic data (age, weight, height, etc.) and their basal systolic, diastolic and mean blood pressures and heart rates were measured prior to the operation and recorded on the case report form.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: August 11, 2020
• Study Start: April 22, 2019
• Primary Completion: October 3, 2019
• Study Completion: February 28, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

TU (1)