目的

通过随机对照研究，探究改良神经监测气管导管插管流程联合早期经口饮食对甲状腺手术患者术后恢复质量的影响。

方法

本研究为前瞻性、单中心、2×2、随机对照研究。我们选取在北京协和医院接受甲状腺手术且行术中神经监测的患者，满足条件的患者被随机分入改良神经监测气管导管插管流程组（M组）或传统神经监测气管导管插管流程组（C组）。当患者术后进入麻醉恢复室且Steward评分≥4时，将被再次随机分入两组，分别接受早期经口饮食（E组）或延迟经口饮食（D组）。患者在住院期间接受随访，并记录术前1天、术后第1天、出院当天的15项恢复质量量表（QoR-15）评分、患者满意度、术后疼痛（包括切口痛和咽痛，使用VAS评分进行评估）、术后不适感（包括口渴感、饥饿感，使用NRS评分进行评估）、插管时间和气管插管再调整率、胃肠道功能恢复时间、引流量、术后住院时间、不良事件。术后第一天的QoR-15评分将作为主要结局指标。

结果

最终入组200例患者。与C组相比，M组患者术后第一天的QoR-15评分无显著差异（均值差: 1.4, 95% CI: -2.5~5.3），但插管用时更短（中位数差: -13.0s, 95% CI: -24.0~-3.0），首次饮水前切口痛及咽痛更轻微（VAS评分中位数差: -0.8, 95% CI: -1.1~-0.1; VAS评分中位数差: -0.9, 95% CI: -1.2~-0.2）。与D组相比，E组患者的术后第一天QoR-15评分无显著差异（均值差=0.0, 95% CI: -3.9~3.9），首次饮水前咽痛更明显（VAS评分中位数差: 0.6, 95% CI: 0.0~1.1），但口渴感与饥饿感更轻微（NRS评分中位数差: -1.0, 95% CI: -1.0~0.0; NRS评分中位数差: -1.0, 95% CI: -2.0~-1.0）。插管流程与术后饮食策略在对术后第一天QoR-15评分的影响中无显著交互效应（F=0.119, p=0.730）。

Objective

To explore the effect of modified intubation protocol of nerve-monitoring endotracheal tube (ETT) combined with early oral intake on postoperative recovery quality in thyroid surgery through a randomized controlled study.

Methods

This study was a prospective, single-center, 2×2 factorial, randomized controlled trial. We recruited patients who received thyroid surgery under intraoperative nerve monitoring at Peking Union Medical College Hospital. Eligible patients were randomly divided into two groups, which received either the modified intubation protocol of nerve-monitoring ETT (M group), or conventional intubation protocol of nerve-monitoring ETT (C group). After patients entered postanesthetic care unit and Steward scores ≥ 4, they were randomly divided into two groups again, which received early oral intake (E group) or delayed oral intake (D group). Patients were followed up during hospitalization, and Quality of Recovery−15 (QoR-15) scores on the day before surgery, QoR-15 scores on the first day after surgery, QoR-15 scores on the day of discharge, patient satisfaction, the postoperative pain (including incisional pain and pharyngalgia, assessed by VAS score), the postoperative discomfort (including thirst, hunger, assessed by NRS score), intubation time and endotracheal intubation readjustment rate, gastrointestinal recovery time, drainage volume, postoperative hospital stay length, adverse events were collected and analyzed. The mean QoR-15 scores on the first day after surgery were regarded as primary outcome.

Results

200 patients were enrolled totally. Compared with Group C, there was no significant difference in QoR-15 scores on the first day after surgery in Group M (Mean difference: 1.4; 95% CI: -2.5~5.3), but the time for intubation was shorter (Median difference: -13.0s; 95% CI: -24.0~-3.0) and the incision pain and pharyngalgia before oral intake were milder (VAS score median difference:-0.8; 95% CI: -1.1~-0.1; VAS score median difference: -0.9, 95% CI: -1.2~-0.2). Compared with group D, there was no significant difference in QoR-15 scores on the first day after surgery for patients in group E (Mean difference: 0.0; 95% CI: -3.9~3.9), who had more severe pharyngalgia (VAS score median difference: 0.6; 95% CI: 0.0~1.1) but less thirst and hunger before oral intake (NRS score median difference: -1.0; 95% CI: -1.0~0.0; NRS score median difference: -1.0, 95% CI: -2.0~-1.0). There was no significant interaction effect between intubation protocol and postoperative oral intake strategy on QoR-15 score on the first day after surgery (F=0.119, p=0.730).

Conclusions

In this randomized controlled study, the modified intubation protocol of nerve-monitoring ETT, early oral intake, and the combined use of different intubation protocol and postoperative oral intake strategie did not show a significant impact on the postoperative recovery quality of thyroid surgery patients. However, the modified intubation protocol of nerve-monitoring ETT might have a positive effect on shortening the intubation time and alleviating early postoperative pain, and early oral intake could alleviate the discomfort of long-term fasting after surgery.