Abstract
Objectıve
The objective of this randomized double blind study was to evaluate effect of the premedication with oral clonidine on blood pressure, cleaning of surgical site and bleeding in the ESS performed due to advanced NP.
Methods
A total of 52 patients who underwent functional endoscopic sinus surgery (FESS) due to Kennedy grade 4 nasal polyposis (NP) were included. Patients were randomized into two groups. Group 1 (n = 26) received 0.2 mg oral clonodine one hour before the operation in addition to standard anesthesia procedure. Group 2 (n = 26) was administered standard anesthesia procedure alone. The amount of bleeding during surgery, cleaning of surgical site and surgeon’s satisfaction were evaluated in comparison between the groups.
Results
The amount of bleeding and mean arterial pressure were significantly lower in the Group 1 compared to the Group 2. The cleaning of surgical site was found to be significantly better and surgeon’s satisfaction significantly higher in the Group 1 than in the Group 2. Systolic, diastolic and mean arterial pressures during surgery were significantly lower in the Group 1 compared to the Group 2.
Conclusion
Premedication with oral clonidine provides a clearer view of surgical site, reduces the amount of bleeding and significantly increases surgeon’s satisfaction during the operation in FESS performed due to NP. Premedication with oral clonidine is a safe, inexpensive and effective methods in order to increase the surgical success and comfort and reduce complications in the FESS surgery.
1
Introductıon
Functional endoscopic sinus surgery (FESS) is currently the most commonly used surgical method for the treatment of chronic sinusitis and nasal polyposis cases that are unresponsive to medical therapy. Despite a number of application to improve surgical site, bleeding during ESS remains a serious problem for both surgeons and anesthetists . A great amount of bleeding in the surgical site during ESS may lead to distortion of the endoscopic view, increased possibility of complications, prolongation of the time of surgery and sometimes to an inadequately performed surgery . Since anatomic landmarks determine the basis of FESC, the degree of bleeding which occurs during surgery is important and may cause overlook of these landmarks. It is recommended to use preoperative systemic/topical corticosteroids especially in patients with nasal polyposis in order to avoid such problems. Despite these measures, bleeding and the condition of surgical site may not be at a desired levels during the operation.
Many methods are used to reduce bleeding during FESS. Topical vasoconstrictor drugs may cause hemodynamic instability particularly in patients having a history of ischemic heart disease and hypertension. The induction of hypotension with volatile agents or narcotics may cause giving much anesthetics to the patient, exposing him/her to adverse effects of these drugs. Besides all these, these methods cannot provide optimal bloodless surgical site for a long time .
Clonidine is a drug with increasing popularity as an adjuvant in anesthesia because of its positive influence on hemodynamic profile in addition to sedative and analgesic effects . Clonidine is an alpha-2 agonist drug causing constriction in the peripheral vessels which has been proven in animal models to reduce nasal mucosal blood flow . Numerous studies have been conducted about clonidine, there are only a few data regarding its effects on bleeding and surgical comfort in advanced nasal polyposis surgery which is among the most common applications of FESS.
The objective of this study is to evaluate effect of premedication with clonidine in the ESS in patients with Kennedy grade 4 NP in terms of bleeding, surgical visual field and surgeon’s satisfaction.
2
Materials & methods
2.1
Study design
We performed this study following approval of the local medical ethics committee. A total of 52 patients scheduled for FESS due to Kennedy grade 4 NP from November 2014 through May 2015 were included in the study. Patients were taken to the operation in turn with one patient was randomly given drug (0.2 mg clonidine) 1 hour before the surgery and the next was not given by the department nurse. Group 1 received standard anesthesia protocol + clonidine = SAP + Clon (n = 26) and Group 2 standard anesthesia protocol = SAP (n = 26).
The surgeon who performed the surgery and anesthetist were unaware of which patients were administered drugs. The data were collected by the operating nurse who was blinded to the objective of the study. ASA value was 1 or 2 in all the participants. A packing was preoperatively inserted in to the nasopharynx of all patients and a new aspirator bag was placed. All patients were placed in a 10 degree reverse Trendelenburg position during the surgery. With the same anesthetic and surgical team with the same technique, all the patients were operated using a shaver. Written consent was obtained from all the patients.
The exclusion criteria include the patients operated with the diagnosis of chronic sinusitis, having Kennedy grade 1-2-3 nasal polyps, bleeding diathesis in the preoperative evaluation, chronic systemic disease in an extend that will not allow controlled hypotension, those using drugs that may affect the study (anticoagulants, calcium channel blockers, digoxin, aspirin, beta blockers), patients weighing less than 50 or greater than 100 kg, those had taken clonidine, neuroleptics and antidepressants due to another diagnosis before surgery and patients with a systolic blood pressure over 160 mmHg and a diastolic blood pressure over 90 mmHg in the preoperative evaluation.
2.2
Anesthesia
After the patients were taken into the operating room, standard monitoring protocol was implemented through ECG, non-invasive blood pressure and pulse oximetry. Intravenous midazolam (0.03 mg/kg) was administered before the drug. Baseline heart rate and mean arterial pressure values were determined. Anesthesia induction was achieved with 1 mg/kg lidocaine and 1 mg/kg propofol followed by total intravenous anesthesia (TIVA) with propofol and remifentanil infusion. Rocuronium 0.6 mg/kg was administered in order to facilitate tracheal intubation. Remifentanil infusion was initiated and maintained as 0.25 μg kg −1 min −1 .
2.3
Evaluation
- •
Hematological parameters: hemoglobin, hematocrit, platelet, PT, APTT levels.
- 1.
Evaluation of nasal function: nasal obctruction in the patients was evaluated with NOSE scale which is commonly used in the literature .
- 2.
The degree of bleeding in surgical site: at the end of the surgery, the surgical field was graded in terms of bleeding by the surgeon using the scale developed by Boezaart .
- 3.
The amount of bleeding: the amount of fluid in the aspirator was calculated by weighing the nasopharyngeal packing before and after the operation.
- 4.
Time of surgery: it was defined as the time between delivering the patient to the surgeon and completion of the operation.
- 5.
Surgeon’s satisfaction: surgeon’s satisfaction of the surgical site was defined based on the Likert scale (5: very satisfied, 4: satistied 3: neither satisfied nor unsatisfied, 2: unsatisfied, 1: very unsatisfied).
- 6.
Hemodynamic monitoring: systolic and diastolic blood pressure and pulse were recorded with 15-minute intervals.
2
Materials & methods
2.1
Study design
We performed this study following approval of the local medical ethics committee. A total of 52 patients scheduled for FESS due to Kennedy grade 4 NP from November 2014 through May 2015 were included in the study. Patients were taken to the operation in turn with one patient was randomly given drug (0.2 mg clonidine) 1 hour before the surgery and the next was not given by the department nurse. Group 1 received standard anesthesia protocol + clonidine = SAP + Clon (n = 26) and Group 2 standard anesthesia protocol = SAP (n = 26).
The surgeon who performed the surgery and anesthetist were unaware of which patients were administered drugs. The data were collected by the operating nurse who was blinded to the objective of the study. ASA value was 1 or 2 in all the participants. A packing was preoperatively inserted in to the nasopharynx of all patients and a new aspirator bag was placed. All patients were placed in a 10 degree reverse Trendelenburg position during the surgery. With the same anesthetic and surgical team with the same technique, all the patients were operated using a shaver. Written consent was obtained from all the patients.
The exclusion criteria include the patients operated with the diagnosis of chronic sinusitis, having Kennedy grade 1-2-3 nasal polyps, bleeding diathesis in the preoperative evaluation, chronic systemic disease in an extend that will not allow controlled hypotension, those using drugs that may affect the study (anticoagulants, calcium channel blockers, digoxin, aspirin, beta blockers), patients weighing less than 50 or greater than 100 kg, those had taken clonidine, neuroleptics and antidepressants due to another diagnosis before surgery and patients with a systolic blood pressure over 160 mmHg and a diastolic blood pressure over 90 mmHg in the preoperative evaluation.
2.2
Anesthesia
After the patients were taken into the operating room, standard monitoring protocol was implemented through ECG, non-invasive blood pressure and pulse oximetry. Intravenous midazolam (0.03 mg/kg) was administered before the drug. Baseline heart rate and mean arterial pressure values were determined. Anesthesia induction was achieved with 1 mg/kg lidocaine and 1 mg/kg propofol followed by total intravenous anesthesia (TIVA) with propofol and remifentanil infusion. Rocuronium 0.6 mg/kg was administered in order to facilitate tracheal intubation. Remifentanil infusion was initiated and maintained as 0.25 μg kg −1 min −1 .
2.3
Evaluation
- •
Hematological parameters: hemoglobin, hematocrit, platelet, PT, APTT levels.
- 1.
Evaluation of nasal function: nasal obctruction in the patients was evaluated with NOSE scale which is commonly used in the literature .
- 2.
The degree of bleeding in surgical site: at the end of the surgery, the surgical field was graded in terms of bleeding by the surgeon using the scale developed by Boezaart .
- 3.
The amount of bleeding: the amount of fluid in the aspirator was calculated by weighing the nasopharyngeal packing before and after the operation.
- 4.
Time of surgery: it was defined as the time between delivering the patient to the surgeon and completion of the operation.
- 5.
Surgeon’s satisfaction: surgeon’s satisfaction of the surgical site was defined based on the Likert scale (5: very satisfied, 4: satistied 3: neither satisfied nor unsatisfied, 2: unsatisfied, 1: very unsatisfied).
- 6.
Hemodynamic monitoring: systolic and diastolic blood pressure and pulse were recorded with 15-minute intervals.
3
Statistical analysis
The statistical tests were conducted using the Statistical Package for the Social Sciences version 13.0 for Windows (SPSS Inc., Chicago, IL). All quantitative variables were estimated using measures of central location (i.e., mean and median) and measures of dispersion (i.e., standard deviation [SD]). Data normality was tested using the Kolmogorov–Smirnov tests of normality. Mann–Whitney U test was used in comparison of data varying with measuring and Fisher exact test was utilized in comparison of data varying with counting.
4
Results
There was not a significant difference in mean age between the Group1 (SAP + Clonidine) (43.2 ± 8.3) and the Group 2 (SAP) (41.9 ± 6.7) ( p = .395) ( Table 1 ). The two groups also did not show a statistically significant difference in terms of gender ( p = .419) ( Table 1 ). No significant difference was found in body weight between the groups (69.7 ± 11.5 and 72.4 ± 10.9; respectively) ( p = .267) ( Table 1 ).
