Importance: Free flap surgery is a lengthy procedure with massive tissue destruction and reconstruction, which makes postoperative pulmonary complications (PPCs) a noticeable issue among patients with head and neck cancer. Propofol-based total intravenous anesthesia (TIVA) has better survival outcomes than inhalational anesthesia (INH) in several types of cancer surgery. A previous retrospective study found that patients in the TIVA group had a lower PPC rate, which may be correlated with a lower intraoperative fluid requirement. We hypothesize that the protective effect remains among patients undergoing free flap surgery for head and neck cancer in a prospective and goal-directed fluid therapy setting.
Objective: To assess the effect of TIVA vs INH on PPCs in patients undergoing microvascular reconstruction for head and neck cancer.
Design, setting, and participants: This prospective, 2-arm, randomized clinical trial was conducted at a tertiary hospital in Taiwan; a total of 78 patients 18 years and older with American Society of Anesthesiologists physical status classification 1 to 3 who were scheduled for elective free flap surgery under general anesthesia were included. The trial started in October 2017, completed in October 2019, and finished analysis in January 2022.
Interventions: Patients were enrolled and randomized to the TIVA or INH group. All patients received goal-directed fluid therapy and hemodynamic management if they had a mean arterial pressure (MAP) below 75 mm Hg or a reduction of 10% from baseline MAP.
Main outcomes and measures: The primary outcome was a composite of PPCs. The secondary outcomes were the differences in intraoperative hemodynamic values (mean arterial pressure, MAP; cardiac index, CI; systemic vascular resistance index, SVRI; and stroke volume variation, SVV).
Results: A total of 70 patients (65 men [93%]; 5 women [7%]) completed the trial; median (IQR) age was 52.0 (48-59) years in the TIVA group and 57.0 (46-64) years in the INH group. The demographic characteristics were similar between the 2 groups, except that patients in the TIVA group had a slightly lower body mass index. Patients in the TIVA group had a lower risk of developing PPCs (unadjusted odds ratio, 0.25; 95% CI, 0.08-0.80). The TIVA group had significantly higher MAP, lower CI, and higher SVRI than the INH group after the third hour of monitoring. The TIVA group showed a relatively stable hourly MAP, CI, SVRI, and SVV across time points, while the INH group showed a more varying pattern. The generalized estimating equation showed no clinical differences in the trend of hemodynamic parameters across time between groups.
Conclusions and relevance: In this randomized clinical trial, using propofol-based TIVA reduced the incidence of PPCs in free flap surgery. This finding may be related to more stable hemodynamic manifestations and a lower total balance of fluid throughout the surgery.
Trial registration: ClinicalTrials.gov Identifier: NCT03263078.