Department of Anesthesia and Critical Care, Provincial General Referral Hospital of Bukavu, Bukavu, Democratic Republic of Congo.
Faculty of Medicine, Catholic University of Bukavu, Bukavu, Democratic Republic of Congo.
BMC Anesthesiol. 2024 Nov 25;24(1):425. doi: 10.1186/s12871-024-02809-x.
Functional endoscopic sinus surgery (FESS) is minimally invasive, ambulatory endoscopic surgical procedure usually performed in most paranasal sinus diseases. Controlled hypotension during anaesthesia (hypotensive anesthesia) improves surgical field visibility and reduces risk of injuring surrounding structures. Clonidine (C) and dexmedetomidine (D) are both used to reduce blood pressure and heart rate while maintaining tissue perfusion. This study was conducted to evaluate the efficacy of clonidine compared to dexmedetomidine for controlled hypotension during FESS.
After ethical approval, 80 patients undergoing elective FESS were included in the study and randomly allocated to Group C or Group D. In Group C, 40 patients received intravenous clonidine with a loading dose of 3µg/Kg for 10 min and titrated maintenance dose of 0.4-0.8 µg/Kg/hour. In Group D patients received intravenous dexmedetomidine with a loading dose of 1µg/Kg for 10 min and titrated maintenance dose of 0.4-0.8µg/Kg/hour. The target was mean arterial blood pressure (MAP) between 55 and 65 mmHg and heart rate (HR) above 50 beats per minute. The primary outcome was blood loss. The secondary outcomes were surgical field quality assessed by Fromme Bezooart score, variations in MAP and HR intraoperatively, duration of surgery and anesthesia, and post-operative sedation assessed by Ramsay Sedation Score (RSS).
Demographic data of both groups were comparable. The difference between both groups in terms of blood loss and surgical field quality was not statistically significant (p = 0.579, 1.000). MAP and HR were statistically significantly reduced to targeted level in both groups compared to baseline (p<0.001). Dexmedetomidine led to severe hypotension compared to clonidine, and the difference was statistically significant. Duration of return to baseline MAP and HR, duration of anesthesia and postoperative sedation were prolonged in group D compared to Group C.
Clonidine and dexmedetomidine provided good to excellent quality of surgical field visibility to surgeons during FESS. Dexmedetomidine produce more hypotension and bradycardia compared to clonidine which may be preferable for controlled hypotension in the setting of ambulatory surgery. However, considering the small sample of this study which could not detect small but clinically differences between both drugs, there is a need for a much larger and multicenter study to confirm these findings.
This trial was retrospectively registered in the Pan African Clinical Registry (pactr.samrc, ac.za) on 15 August 2024 under trial number PACTR202408565688611.
功能性内窥镜鼻窦手术（FESS）是一种微创、门诊内窥镜手术，通常用于治疗大多数鼻窦疾病。麻醉期间的控制性降压（降压麻醉）可提高手术视野的可视性并降低损伤周围结构的风险。可乐定（C）和右美托咪定（D）均可用于降低血压和心率，同时保持组织灌注。本研究旨在评估可乐定与右美托咪定在 FESS 期间控制性降压的疗效。
在获得伦理批准后，纳入 80 例接受择期 FESS 的患者，并将其随机分配到 C 组或 D 组。在 C 组中，40 例患者接受静脉注射可乐定，负荷剂量为 3μg/Kg，持续 10 分钟，然后以 0.4-0.8μg/Kg/小时的维持剂量滴定。在 D 组患者中，接受静脉注射右美托咪定，负荷剂量为 1μg/Kg，持续 10 分钟，然后以 0.4-0.8μg/Kg/小时的维持剂量滴定。目标是平均动脉压（MAP）在 55 至 65mmHg 之间，心率（HR）高于 50 次/分钟。主要结局是出血量。次要结局包括 Fromme Bezooart 评分评估的手术视野质量、术中 MAP 和 HR 的变化、手术和麻醉持续时间以及 Ramsay 镇静评分（RSS）评估的术后镇静。
两组患者的人口统计学数据无差异。两组患者在出血量和手术视野质量方面的差异无统计学意义（p=0.579，1.000）。与基线相比，两组患者的 MAP 和 HR 均显著降低至目标水平（p<0.001）。与可乐定相比，右美托咪定导致更严重的低血压，差异具有统计学意义。与 C 组相比，D 组患者恢复至基线 MAP 和 HR 的时间、麻醉和术后镇静时间延长。
可乐定和右美托咪定在 FESS 期间为外科医生提供了良好至极佳的手术视野可视性。与可乐定相比，右美托咪定可导致更严重的低血压和心动过缓，这可能更适合门诊手术中的控制性降压。然而，考虑到这项研究的样本量较小，无法检测到两种药物之间的微小但临床差异，因此需要进行更大规模的多中心研究来证实这些发现。
该试验于 2024 年 8 月 15 日在泛非临床登记处（pactr.samrc，ac.za）以 PACTR202408565688611 号进行了回顾性注册。
