Introduction: Endoscopic sinus surgery (ESS) is frequently performed under general anesthesia, where intraoperative bleeding can impair visualization and surgical precision. Controlled hypotension using agents like dexmedetomidine or remifentanil may improve surgical field quality and patient outcomes. Objective: To compare the efficacy of continuous infusions of dexmedetomidine and remifentanil in optimizing surgical field quality, surgeon satisfaction, hemodynamic stability, anesthetic requirements, prevention of emergence agitation, and incidence of postoperative nausea and vomiting (PONV). Methods: In this prospective, randomized, double-blinded controlled trial, 60 patients (ASA physical status I–II, aged 18–60 years) undergoing ESS for chronic sinusitis or nasal polyposis were randomized into two groups (n=30 each): Group D (dexmedetomidine infusion at 0.4 mcg/kg/h) and Group R (remifentanil infusion at 0.05 mcg/kg/min). Anesthesia was induced with fentanyl (2 mcg/kg) and propofol (2 mg/kg), and maintained with isoflurane. Hemodynamic parameters (mean arterial pressure [MAP] and heart rate [HR]), surgical field quality (6-point scale), surgeon satisfaction (5-point scale), emergence agitation scores, and PONV incidence were assessed. Data were analyzed using Student's t-test or chi-square test, with p < 0.05 considered significant. Results: Baseline characteristics were comparable between groups. Group R exhibited significantly lower intraoperative MAP and HR at 30-, 60-, and 90-minutes post-incision (p < 0.05), but Group D showed greater hemodynamic stability and lower emergence agitation scores (1.2 ± 0.3 vs. 2.0 ± 0.4; p < 0.05). Surgical field scores (2.0 ± 0.5 vs. 1.8 ± 0.6; p = 0.12) and surgeon satisfaction (4.5 ± 0.4 vs. 4.6 ± 0.3; p = 0.42) were similar. PONV incidence was 10% in Group D and 16% in Group R (p = 0.45). Anesthetic requirements were lower in Group D. Conclusion: Both agents effectively enhance surgical field quality in ESS. Dexmedetomidine provides superior hemodynamic stability and reduced emergence agitation, while remifentanil offers faster hypotension onset. Selection should consider patient-specific factors
Endoscopic sinus surgery (ESS) is a standard procedure for treating chronic rhinosinusitis and nasal polyposis, typically conducted under general anesthesia. Intraoperative bleeding poses a significant challenge, as it reduces endoscopic visibility, complicates instrument manipulation, and may prolong operative time or increase complication risks [1,2]. Controlled hypotension has emerged as an effective strategy to minimize bleeding, thereby improving surgical field quality, precision, and patient safety [3,4].
Dexmedetomidine, a selective α2-adrenergic agonist, induces sedation, analgesia, and sympatholysis with minimal respiratory depression, making it suitable for controlled hypotension [5]. Remifentanil, an ultra-short-acting opioid, provides rapid-onset analgesia and titratable hypotension due to its short half-life [6]. While both agents have been used in ESS to achieve hypotensive anesthesia, comparative studies on their impacts on surgical field quality, hemodynamics, and postoperative outcomes remain limited and inconsistent [7,8].
This study aimed to compare the efficacy of dexmedetomidine and remifentanil infusions in ESS, evaluating: (1) surgical field quality and surgeon satisfaction; (2) hemodynamic stability; (3) intraoperative anesthetic requirements; (4) prevention of emergence agitation; and (5) incidence of PONV. We hypothesized that dexmedetomidine would offer superior hemodynamic stability and reduced postoperative complications compared to remifentanil.
Study Design
This was a prospective, randomized, double-blinded controlled trial conducted at Department of Anesthesia, Government Erode Medical College and Hospital, Perundurai, Erode, Tamilnadu from January 2024 to march 2025. The study protocol was approved by the institutional ethics committee, and written informed consent was obtained from all participants. The trial adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Participants
Sixty patients aged 18–60 years, classified as American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for ESS under general anesthesia for chronic sinusitis or nasal polyposis were enrolled. Exclusion criteria included patient refusal, hemodynamic instability (e.g., baseline MAP <70 mmHg or HR >100 bpm), significant cardiovascular disease, body mass index (BMI) >30 kg/m², or contraindications to study drugs.
Randomization and Blinding
Patients were randomized (1:1 ratio) using a computer-generated list into Group D (dexmedetomidine) or Group R (remifentanil). Allocation was concealed in sealed envelopes. The anesthesiologist preparing the infusions, surgeon assessing outcomes, and patients were blinded to group assignments.
Anesthesia Protocol
Premedication followed institutional standards (e.g., oral midazolam 0.5 mg/kg if needed). Anesthesia induction involved intravenous fentanyl (2 mcg/kg) and propofol (2 mg/kg), followed by endotracheal intubation facilitated by rocuronium (0.6 mg/kg). Maintenance was with isoflurane (1–2% in oxygen/air mixture) titrated to bispectral index (BIS) values of 40–60.
Study drug infusions began at induction and continued until extubation: Group D received dexmedetomidine at 0.4 mcg/kg/h; Group R received remifentanil at 0.05 mcg/kg/min. Intraoperative fluids and vasopressors were administered as needed to maintain MAP between 55–65 mmHg.
Data Collection
Primary Outcomes: Surgical field quality was scored by the blinded surgeon using a 6-point scale (0 = no bleeding; 5 = uncontrollable bleeding) [9]. Surgeon satisfaction was rated on a 5-point Likert scale (1 = very dissatisfied; 5 = very satisfied).
Secondary Outcomes: MAP and HR were recorded at baseline (pre-induction), incision, 30, 60, 90, and 120 minutes post-incision, and 10 minutes post-infusion cessation. Intraoperative anesthetic requirements (isoflurane concentration) were noted. Emergence agitation was assessed using the Richmond Agitation-Sedation Scale (RASS) post-extubation. PONV was evaluated in the post-anesthesia care unit (PACU) using a binary scale (present/absent).
Adverse events, such as bradycardia or hypotension requiring intervention, were monitored.
Statistical Analysis
Sample size was calculated based on prior studies [7], assuming a 20% difference in surgical field scores (α=0.05, power=80%), yielding 30 patients per group. Data normality was assessed with the Shapiro-Wilk test. Continuous variables were analyzed using unpaired Student's t-test or Mann-Whitney U test; categorical data with chi-square or Fisher's exact test. Results are presented as mean ± standard deviation (SD) or percentages. Significance was set at p < 0.05. Analysis was performed using SPSS version 25.0 (IBM Corp., Armonk, NY).
Sixty patients were enrolled and completed the study (Figure 1: CONSORT flow diagram).
Baseline Characteristics
Demographic and clinical baseline data were comparable between groups (Table 1).
Table 1. Baseline Characteristics of Study Participants
Parameter |
Group D (n=30) |
Group R (n=30) |
p-value |
Age (years) |
38.2 ± 9.1 |
39.0 ± 8.7 |
0.72 |
Gender (M/F) |
18/12 |
17/13 |
0.80 |
ASA I/II |
20/10 |
21/9 |
0.78 |
BMI (kg/m²) |
24.5 ± 3.2 |
25.1 ± 3.0 |
0.51 |
Data presented as mean ± SD or counts.
Hemodynamic Parameters
Intraoperative MAP and HR were significantly lower in Group R at 30-, 60-, and 90-minutes post-incision (p < 0.05), but returned to baseline similarly post-infusion (Table 2).
Table 2. Hemodynamic Parameters at Various Time Points
Time Point |
MAP (mmHg) Group D |
MAP (mmHg) Group R |
HR (bpm) Group D |
HR (bpm) Group R |
p-value (MAP/HR) |
Baseline |
93 ± 5 |
92 ± 6 |
78 ± 6 |
77 ± 7 |
>0.05 |
Incision |
85 ± 4 |
84 ± 5 |
72 ± 5 |
70 ± 6 |
>0.05 |
30 min post-incision |
72 ± 4 |
68 ± 3 |
68 ± 5 |
62 ± 4 |
<0.05 |
60 min post-incision |
71 ± 4 |
67 ± 3 |
66 ± 5 |
60 ± 4 |
<0.05 |
90 min post-incision |
72 ± 5 |
67 ± 3 |
67 ± 4 |
61 ± 4 |
<0.05 |
120 min post-incision |
73 ± 4 |
69 ± 4 |
68 ± 5 |
63 ± 5 |
<0.05 |
10 min post-infusion |
85 ± 5 |
83 ± 4 |
75 ± 5 |
73 ± 5 |
>0.05 |
Data presented as mean ± SD.
Surgical Field Quality and Other Outcomes
Surgical field quality and surgeon satisfaction were comparable, but emergence agitation was significantly lower in Group D (p < 0.05). PONV incidence did not differ significantly (Table 3). Intraoperative isoflurane requirements were lower in Group D (mean end-tidal concentration: 1.2% ± 0.2% vs. 1.5% ± 0.3%; p < 0.05).
Table 3. Surgical Field Quality, Satisfaction, and Postoperative Outcomes
Outcome |
Group D (n=30) |
Group R (n=30) |
p-value |
Surgical field score (0–5) |
2.0 ± 0.5 |
1.8 ± 0.6 |
0.12 |
Surgeon satisfaction (1–5) |
4.5 ± 0.4 |
4.6 ± 0.3 |
0.42 |
Emergence agitation score |
1.2 ± 0.3 |
2.0 ± 0.4 |
<0.05 |
PONV incidence (%) |
10 |
16 |
0.45 |
Data presented as mean ± SD or percentages.
No serious adverse events were reported.
This trial demonstrates that both dexmedetomidine and remifentanil effectively facilitate controlled hypotension in ESS, leading to improved surgical field quality. However, dexmedetomidine provided more stable hemodynamics and reduced emergence agitation, consistent with its sympatholytic and sedative properties [5,10]. Remifentanil's rapid onset resulted in lower intraoperative MAP and HR, but with greater variability, aligning with previous findings [6,7].
Surgical field scores were similar, supporting meta-analyses showing comparable bleeding control [11]. Lower anesthetic requirements in Group D may reflect dexmedetomidine's propofol-sparing effects [12]. The non-significant difference in PONV contrasts some studies [13], possibly due to standardized antiemetic prophylaxis.
Limitations include single-center design and lack of long-term follow-up. Future research should explore dose optimizations and combinations with other agents.
Dexmedetomidine and remifentanil both enhance surgical field quality in ESS via controlled hypotension. Dexmedetomidine excels in hemodynamic stability and emergence agitation prevention, while remifentanil provides quicker hypotension. Agent selection should be tailored to patient needs and surgical demands.
Acknowledgments:
The authors would like to thank all of the study participants and the administration of Department of Anesthesia, Government Erode Medical College and Hospital, Perundurai, Erode, Tamilnadu, India for granting permission to carry out the research work.
Conflicts of interest: There are no conflicts of interest.
Ethical statement:
Institutional ethical committee accepted this study. The study was approved by the institutional human ethics committee, Department of Anesthesia, Government Erode Medical College and Hospital, Perundurai, Erode, Tamilnadu. Informed written consent was obtained from all the study participants and only those participants willing to sign the informed consent were included in the study. The risks and benefits involved in the study and the voluntary nature of participation were explained to the participants before obtaining consent. The confidentiality of the study participants was maintained.
Funding: Nil.
Authors’ contributions:
Dr.Kousalya T: Conceptualization, Formal analysis, Project administration, Writing‑original draft, Validation, Investigation. Dr. Kokila T : Conceptualization, Writing‑review and editing, Formal analysis, Validation, Investigation, Visualization. Dr. Dr.Gayathri B: Conceptualization, Methodology, Writing‑review and editing, Validation, Resources. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. All authors have read and agreed to the published version of the manuscript.
DATA AVAILABILITY:
All datasets generated or analysed during this study are included in the manuscript.
INFORMED CONSENT:
Written informed consent was obtained from the participants before enrolling in the study.