Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Neoplasms Malignant Surgical Procedures, Operative Stomach Neoplasms Pancreatic Cancer, Adult | Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. | Not Applicable |
A study was approved by institutional ethics committee. All patients were informed on the study protocol by attending anesthesiologist on the day of the surgery and written informed consent was obtained. Patients with clinically or radiologically confirmed acute respiratory infections or those using antibiotics due to the respiratory infections a week prior to the surgery were not included in the study. Following risk factors were recorded in all patients: age, sex, weight loss in the last 6 months, comorbidities and operative time. Comorbidities were rated using ASA status and Charlson comorbidity index by 3 independent observers. Charlson comorbidity index was calculated after pathological examination. An advanced malignant disease was considered if tumor had infiltrated other organs or surrounding tissues, or when positive lymph nodes or metastases were confirmed.
A group of 120 colorectal, gastric, or pancreatic cancer patients scheduled for surgery in the single centre were included in the prospective randomized study regardless of their ASA physical status. Nasopharyngeal smears were obtained in the preoperative area and tracheal aspirates were obtained in the operating room at the end of the surgery with a sterile suction catheter in a closed system.
Postoperative Hgb; CRP and lung auscultation were done in all patients on the second and fourth postoperative day.
Outcome measures registered were:
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | To investigate whether productive cough, dyspnea and hoarseness were different between two groups of patients. Group Air received sevoflurane anesthesia with 35% O2 in air, and Group N2O received sevoflurane anesthesia with 35% O2 in N2O |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Masking Description: | Postoperative outcomes were registered by doctor who did not know type of anesthesia delivered |
Primary Purpose: | Screening |
Official Title: | Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Group air
Group air was mechanically ventilated using 35% oxygen in 65% air during the whole surgical procedure. Thiopental sodium was used for induction of anesthesia, muscle relaxation was maintained with vecuronium. General anesthesia with sevoflurane was maintained during the surgical procedure. Intraoperative analgesia was achieved with fentanyl boluses. |
Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.
|
Active Comparator: Group nitrous oxyde (N2O)
Group N2O was mechanically ventilated using 35 % oxygen and 65 % of nitrous oxyde during the surgical procedure. Nitrous oxyde may increase cuff pressure during the general endotracheal anesthesia and result in the respiratory symptoms like sore throat, hoarseness and postoperative cough. Thiopental sodium was used for induction of anesthesia, muscle relaxation was maintained with vecuronium. General anesthesia with sevoflurane was maintained during the surgical procedure. Intraoperative analgesia was achieved with fentanyl boluses. |
Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Slavica Kvolik, MD, PhD | Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia |
Tracking Information | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | June 24, 2019 | ||||||||||
First Posted Date ICMJE | June 28, 2019 | ||||||||||
Last Update Posted Date | July 2, 2019 | ||||||||||
Study Start Date ICMJE | January 2008 | ||||||||||
Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
Change History | |||||||||||
Current Secondary Outcome Measures ICMJE |
One year survival and complications [ Time Frame: One postoperative year ] All the other postoperative complications, including in-hospital hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished.
|
||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Descriptive Information | |||||||||||
Brief Title ICMJE | Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery | ||||||||||
Official Title ICMJE | Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery | ||||||||||
Brief Summary | The goals of this study were to investigate whether two anesthesia regimens, with and without N2O, and bacterial colonization influence respiratory complications after major abdominal surgery for cancer. | ||||||||||
Detailed Description |
A study was approved by institutional ethics committee. All patients were informed on the study protocol by attending anesthesiologist on the day of the surgery and written informed consent was obtained. Patients with clinically or radiologically confirmed acute respiratory infections or those using antibiotics due to the respiratory infections a week prior to the surgery were not included in the study. Following risk factors were recorded in all patients: age, sex, weight loss in the last 6 months, comorbidities and operative time. Comorbidities were rated using ASA status and Charlson comorbidity index by 3 independent observers. Charlson comorbidity index was calculated after pathological examination. An advanced malignant disease was considered if tumor had infiltrated other organs or surrounding tissues, or when positive lymph nodes or metastases were confirmed. A group of 120 colorectal, gastric, or pancreatic cancer patients scheduled for surgery in the single centre were included in the prospective randomized study regardless of their ASA physical status. Nasopharyngeal smears were obtained in the preoperative area and tracheal aspirates were obtained in the operating room at the end of the surgery with a sterile suction catheter in a closed system. Postoperative Hgb; CRP and lung auscultation were done in all patients on the second and fourth postoperative day. Outcome measures registered were:
|
||||||||||
Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: To investigate whether productive cough, dyspnea and hoarseness were different between two groups of patients. Group Air received sevoflurane anesthesia with 35% O2 in air, and Group N2O received sevoflurane anesthesia with 35% O2 in N2O Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Postoperative outcomes were registered by doctor who did not know type of anesthesia delivered Primary Purpose: Screening
|
||||||||||
Condition ICMJE |
|
||||||||||
Intervention ICMJE | Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.
|
||||||||||
Study Arms ICMJE |
|
||||||||||
Publications * |
|
||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||
Recruitment Information | |||||||||||
Recruitment Status ICMJE | Completed | ||||||||||
Actual Enrollment ICMJE |
120 | ||||||||||
Original Actual Enrollment ICMJE | Same as current | ||||||||||
Actual Study Completion Date ICMJE | March 2012 | ||||||||||
Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||||
Sex/Gender ICMJE |
|
||||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||
Listed Location Countries ICMJE | Not Provided | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT04002128 | ||||||||||
Other Study ID Numbers ICMJE | 01 | ||||||||||
Has Data Monitoring Committee | No | ||||||||||
U.S. FDA-regulated Product |
|
||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||
Responsible Party | Osijek University Hospital | ||||||||||
Study Sponsor ICMJE | Osijek University Hospital | ||||||||||
Collaborators ICMJE | Josip Juraj Strossmayer University of Osijek | ||||||||||
Investigators ICMJE |
|
||||||||||
PRS Account | Osijek University Hospital | ||||||||||
Verification Date | June 2019 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |