Benign Neoplasm of Cervix UteriNCT04508387
The Effects of CO2 Pneumoperitoneum at Different Temperature in Laparoscopic Surgery
A study testing Group HH (heated-humidified) in people with Benign Neoplasm of Cervix Uteri and Gynecological Laparoscopy, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Neoplasm of Cervix Uteri, Gynecological Laparoscopy
- What is being tested?
- Group HH (heated-humidified)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II patients aged 40-65 who underwent laparoscopic hysterectomy for benign pathology.
Who cannot join
- Patients with chronic obstructive pulmonary disease, asthma, advanced liver and kidney disease, infection, bleeding disorder and drug allergies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Asuman Sargin
Izmir, Anesthesiology and Reanimation, Ege Uni, 35040
About this study
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
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.
Read the 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.
- Being tested
- Group HH (heated-humidified)
- Keywords
- Gynecological laparoscopy, standard CO2, heated-humidified CO2, hemodynamic parameters, respiratory parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group HH (heated-humidified)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Group HH (heated-humidified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic parameters: diastolic and mean blood pressure
diastolic and mean blood pressure
Measured: In the operation period
body temperature
body temperature
Measured: In the operation period
respiratory parameters: tidal volume
tidal volume
Measured: In the operation period
Secondary outcomes (2)
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)
Measured: 24 hour
morphine consumption
pain
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start22 Apr 2019
- Primary completion3 Oct 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Benign Neoplasm of Cervix UteriStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asuman özdemir, Ege University
- Investigators
- Ilkben gunusen, 1, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508387
- Sponsor's protocol ID
- EGE19-3.1/40
- Status last verified
- Aug 2020
- First submitted
- 14 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30457909Birch 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.
PubMed 27760282Cheong 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.
PubMed 29991201Gunusen 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.
PubMed 33888367
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04508387
- Acronym / sponsor ID
- EGE19-3.1/40
- Keywords
- Gynecological laparoscopy, standard CO2, heated-humidified CO2, hemodynamic parameters, respiratory parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group HH (heated-humidified) patients | Active comparator | Procedure: 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 | Placebo comparator | Procedure: 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I-II patients aged 40-65 who underwent laparoscopic hysterectomy for benign pathology.
Key exclusion criteria (1 listed)
- Patients with chronic obstructive pulmonary disease, asthma, advanced liver and kidney disease, infection, bleeding disorder and drug allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group CD (cold-dry) patients, Group HH (heated-humidified) patients |
Primary outcome
hemodynamic parameters: diastolic and mean blood pressure
Time frame: In the operation period
diastolic and mean blood pressure
body temperature
Time frame: In the operation period
body temperature
respiratory parameters: tidal volume
Time frame: In the operation period
tidal volume
2 secondary outcomes
Visual Analogue Scale
Time frame: 24 hour
morphine consumption
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Background: PubMed 30457909Scott 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.
- Results publication: PubMed 27760282Birch 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.
- Results publication: PubMed 29991201Cheong 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.
- Derived from this study: PubMed 33888367Gunusen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilkben gunusen, 1 study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group HH (heated-humidified) in people with Benign Neoplasm of Cervix Uteri and Gynecological Laparoscopy, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic parameters: diastolic and mean blood pressure (time frame: In the operation period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508387, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.