Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

NCT ID: NCT04002128

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-03-31

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:

• Postoperative pneumonia
• Productive and difficult cough
• Dysphonia
• Congestive heart failure
• postoperative complications, including hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished & one year survival

Conditions

Colorectal Neoplasms Malignant; Surgical Procedures, Operative; Stomach Neoplasms; Pancreatic Cancer, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.

Intervention Type: OTHER

Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.

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.

Group Type: ACTIVE_COMPARATOR

Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.

Intervention Type: OTHER

Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients diagnosis of gastric cancer, or colorectal cancer or pancreatic cancer
• Scheduled for major abdominal surgery with organ resections
• Written informed consent
• Nasopharyngeal smears taken in the preoperative area
• Tracheal aspirates taken at the end of the surgical procedure

Exclusion Criteria

• Patients unable to understand study protocol and patients who refused study participation at any time
• patients with clinically or radiologically confirmed acute respiratory infections at admission
• antibiotic therapy due to the respiratory infections a week prior to the surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role: collaborator

Osijek University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Slavica Kvolik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia

References

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Reference Type: BACKGROUND

PMID: 26259742 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 11412514 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 8494136 (View on PubMed)

Braz JR, Volney A, Navarro LH, Braz LG, Nakamura G. Does sealing endotracheal tube cuff pressure diminish the frequency of postoperative laryngotracheal complaints after nitrous oxide anesthesia? J Clin Anesth. 2004 Aug;16(5):320-5. doi: 10.1016/j.jclinane.2004.03.001.

Reference Type: BACKGROUND

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Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id