Skip to main content
OpenTrials
Completed

NCT Number: NCT04508387

The Effects of CO2 Pneumoperitoneum at Different Temperature in Laparoscopic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Benign Neoplasm of Cervix Uteri Gynecological Laparoscopy

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Asuman Sargin

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. hemodynamic parameters: diastolic and mean blood pressure

    Time frame: In the operation period

    diastolic and mean blood pressure

  2. body temperature

    Time frame: In the operation period

    body temperature

  3. respiratory parameters: tidal volume

    Time frame: In the operation period

    tidal volume

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: 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)

  2. morphine consumption

    Time frame: 24 hour

    pain

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 11, 2020
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.