The Effects of CO2 Pneumoperitoneum at Different Temperature in Laparoscopic Surgery

Gynecological Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508387
• Other study ID #: EGE19-3.1/40
• Status: Completed
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: August 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The sample consisted of 100 American Society of Anesthesiologists (ASA) physical status I-II patients aged 40-65 who underwent laparoscopic hysterectomy for benign pathology. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2020
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Benign Neoplasm of Cervix Uteri
• Gynecological Laparoscopy
• Neoplasms
• Pneumoperitoneum
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Group HH (heated-humidified)
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.

Locations

Country	Name	City	State
Turkey	Asuman Sargin	Izmir	Anesthesiology And Reanimation, Ege Uni

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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:CD007821. Review. — View Citation

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. — View Citation

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. Erratum in: Am J Vet Res. 2019 Jan;80(1):73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodynamic parameters: diastolic and mean blood pressure	diastolic and mean blood pressure	In the operation period
Primary	body temperature	body temperature	In the operation period
Primary	respiratory parameters: tidal volume	tidal volume	In the operation period
Secondary	Visual Analogue Scale	The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'.(VAS:0 no pain, VAS:10 very severe pain)	24 hour
Secondary	morphine consumption	pain	24 hour