A randomized trial to evaluate a modified tracheal catheter with upper and lower balloons for anesthetic administration: effect on the cardiovascular, stress response, and comfort in patients undergoing laparoscopic cholecystectomy.

Background: We aimed to evaluate a modified endotracheal tube containing upper and lower balloons for anesthetic administration among patients undergoing laparoscopic cholecystectomy.

Methods: Ninety patients scheduled to undergo laparoscopic cholecystectomy were randomly allocated to 3 equal groups: group A (conventional tracheal intubation without endotracheal anesthesia); B (conventional tracheal intubation with endotracheal anesthesia); and C (tracheal intubation using a modified catheter under study). Blood pressure, heart rate, angiotensin II level, blood glucose level, airway pressure before anesthesia (T1) were measured immediately after intubation (T2), 5 min after intubation (T3), and immediately after extubation (T4). The post-extubation pain experienced was evaluated using the Wong-Baker Face Pain scale. Adverse reactions within 30 min after extubation were recorded.

Results: Systolic blood pressure, diastolic blood pressure, angiotensin II, and blood sugar level in group C at T2, T3 and T4, and heart rate at T2 and T4 were significantly lower than those in group A (P < 0.05); systolic blood pressure and blood sugar at T4, and angiotensin II levels at T2, T3, and T4 were significantly lower than those in group B (P < 0.05). Patients in group C reported the lowest post-extubation pain (P < 0.05 vs. Group A), and the lowest incidence of adverse events such as nausea, vomiting, and sore throat than that in groups A and B (P < 0.05).

Conclusion: The modified endotracheal anesthesia tube under study is effective in reducing cardiovascular and tracheal stress response, and increasing patient comfort, without inducing an increase in airway resistance.

Trial Registration: The clinical trial was retrospectively registered at the Chinese Clinical Trial Registry with the Registration Number ChiCTR1900020832 at January 20th 2019.