The Effects of CO2 Pneumoperitoneum at Different Temperature in Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Benign Neoplasm of Cervix Uteri; Gynecological Laparoscopy
• Interventions: Procedure: Group HH (heated-humidified)

• Registration Number: NCT04508387
• Lead Sponsor: Ege University

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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-22
• Primary Completion: 2019-10-03
• Study Completion: 2020-02-28
• Study First Submitted: 2020-07-14
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-11
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group HH (heated-humidified) patients	Group HH (heated-humidified)	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.
Group CD (cold-dry) patients	Group HH (heated-humidified)	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.

Primary Outcome Measures

Name	Time	Method
respiratory parameters: tidal volume	In the operation period	tidal volume
hemodynamic parameters: diastolic and mean blood pressure	In the operation period	diastolic and mean blood pressure
body temperature	In the operation period	body temperature

Secondary Outcome Measures

Name	Time	Method
morphine consumption	24 hour	pain
Visual Analogue Scale	24 hour	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)

Trial Locations

Locations (1)

Asuman Sargin; 🇹🇷 İzmir, Anesthesiology And Reanimation, Ege Uni, Turkey