Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| morphine consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ilkben gunusen, 1 | Ege University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asuman Sargin | Izmir | Anesthesiology and Reanimation, Ege Uni | 35040 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30457909 | Background | 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. | |
| 27760282 |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2019 | Aug 17, 2020 | Prot_002.pdf |
Not provided
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.
Not provided
Not provided
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.
|
pain |
| 24 hour |
| Result |
| 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. |
| 29991201 | 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. |
| 33888367 | Derived | 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. |