Clinical trial · Interventional

Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

NCT04002128CI-TRIAL-00076386completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colorectal Neoplasms Malignant	—	UNRESOLVED	—
Pancreatic Cancer, Adult	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.85
Stomach Neoplasms	Gastric Neoplasm	ALIAS	0.90
Surgical Procedures, Operative	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
PLACEBO_COMPARATOR
label
Group air
description
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.
interventionNames
1. Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
type
ACTIVE_COMPARATOR
label
Group nitrous oxyde (N2O)
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 90 Years

Show eligibility criteria text

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

References

Publications (5)

BACKGROUNDEvaristo-Mendez G, Rocha-Calderon CH. [Risk factors for nosocomial pneumonia in patients with abdominal surgery]. Cir Cir. 2016 Jan-Feb;84(1):21-7. doi: 10.1016/j.circir.2015.05.051. Epub 2015 Aug 8. Spanish. PMID 26259742
BACKGROUNDFernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065. PMID 27829093
BACKGROUNDde Albuquerque Medeiros R, Faresin S, Jardim J. [Postoperative lung complications and mortality in patients with mild-to-moderate COPD undergoing elective general surgery]. Arch Bronconeumol. 2001 May;37(5):227-34. doi: 10.1016/s0300-2896(01)75059-4. Spanish. PMID 11412514
BACKGROUNDPayne KA, Miller DM. The Miller tracheal cuff pressure control valve. Clinical use in controlled and spontaneous ventilation. Anaesthesia. 1993 Apr;48(4):324-7. doi: 10.1111/j.1365-2044.1993.tb06954.x. PMID 8494136
BACKGROUNDBraz 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. PMID 15374551