Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery
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|ClinicalTrials.gov Identifier: NCT02484859|
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : September 10, 2019
Last Update Posted : September 17, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Nasal Polyps||Drug: Remifentanil Drug: Tramadol Drug: Metoprolol||Phase 4|
This study aims to compare two techniques for controlled hypotension during FESS. In both cases, the patients will be evaluated during the preoperative anesthetic visit, and will be given care by an anesthesiologist during the perioperative period.
Patients who are scheduled for an elective FESS operation will be included in the study. During the preoperative anaesthetic visit, patients who do not meet any of the the exclusion criteria will be offered to participate in hte study. Patients accepting to contribute tot he study will be randomised into one of the two groups via closed envelope technique.
A pilot study with 20 patients resulted in similar means and slightly different standard deviations of mean blood pressure. This pilot study showed that 44 patients in each group are sufficient to obtain 80% power with an alpha error of 0.05 and beta error of 20%. To compensate for missing/inconsistent data, or allow for better matching of the demographic variables, 3-5 additional patients will be recruited.
The anesthesiologist in charge of the patient will not be blinded to the groups, and will be responsible for maintaining the hypotension (and patient safety) with either remifentanil in one group, or tramadol and metoprolol in the other group. Systolic, diastolic, and mean blood pressures, and heart rate will be recorded into a spreadsheet every three minutes during the anaesthetic and surgical period. The data will be recorded via an excel form, which will validate the entries upon entrance. The accuracy and completeness of registry data will be verified by a third investigator, who will compare the registry data to the medical monitor records at the end of each operative day.
The surgeon will be blinded to the groups, and will be responsible for scoring the surgical vision and bleeding with the intraoperative bleeding score. The study drugs will be administered via the same type of infusion pump to facilitate the blinding process.
Any adverse event will be reported in the patient chart and study records.
Statistical analysis will be carried out using R and Statistical Package for the Social Sciences (SPSS) programs. Demographic variables (age, gender, American Society of Anesthesiologists (ASA) score, comorbidities) will be analysed using descriptive statistics. Study variables such as duration of operation, variance of the hemodynamic parameters, amount of bleeding, bleeding score, occurrence of adverse events will be analysed with the appropriate statistical tests.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Normotensive Anesthesia Using a Combination of Metoprolol and Tramadol With Controlled Hypotension Using Remifentanil in Endoscopic Sinus Surgery|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||February 2016|
Active Comparator: remifentanil
Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
Remifentanil infusion will be started with a bolus dose of 0.5 µg/kg before the induction, and will be continued throughout the surgery at a dose of 0.25-0.5 µg/kg/min. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
Other Name: Ultiva
Active Comparator: tramadol + metoprolol
Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
1 mg/kg tramadol will be added to 100 ml of isotonic fluid, and will be administered intravenously in exactly 30 minutes via a perfusor. The infusion will be started just before the induction.
Other Name: Contramal
0.1 mg/kg of metoprolol will be administered intravenously within 5 minutes following the administration of neuromuscular blocking agent.
Other Name: Beloc
- Intraoperative Bleeding Score [ Time Frame: throughout surgery, up to 3 hours ]
Intraoperative bleeding score is reported by the surgeon according to Boezaart Surgical Field Grading scale. The scale ranges from 0 to 5. '0' is the best, and '5' is the worst outcome.
The scale construct is:
0 No bleeding.
- Slight bleeding, no suction is required.
- Slight bleeding, occasional suctioning required.
- Slight bleeding, frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
- Moderate bleeding, frequent suctioning required. Bleeding threatens surgical field as soon as suction is removed.
- Severe bleeding, constant suctioning required. Bleeding appears faster than suctioning.
Thoroughout the intraoperative period, the surgeon is free to report a score at any time he/she sees appropriate.
- Time to Achieve Intraoperative Bleeding Score < 3 [ Time Frame: throughout surgery, up to 20 minutes ]The intraoperative bleeding score will be reported by the surgeon throughout surgery. At the start of the surgery, a timer will be used to measure the duration to achieve a bleeding score of 2.
- Bleeding Rate [ Time Frame: throughout surgery, up to 3 hours ]In the end of each surgery, bleeding rate will be calculated as ml/min by dividing total bleeding (amount of blood in the graded suction and sponges minus total irrigation fluid) to the duration of surgery (excluding local anesthetic infiltration, and nasal packing).
- Postoperative Pain [ Time Frame: following extubation, up to 24 hours ]Postoperative pain scores on the day of surgery will be evaluated with a visual analog scale (0: no pain, 10: worst pain ever) at the post anaesthetic care unit (PACU), and the surgical ward. The evaluation will begin after the patient arrives at the post anaesthetic care unit, and will continue for 24 hours.
- Number of Participants With Postoperative Nausea and Vomiting [ Time Frame: following extubation, up to 24 hours ]Postoperative nausea, retching, and vomiting on the day of surgery will be evaluated with a four-point ordinal scale (0-none, 1-nausea, 2-retching, 3-vomiting) at the post anaesthetic care unit, and the surgical ward. The evaluation will begin after the patient arrives at the post anaesthetic care unit, and will continue for 24 hours.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- diagnosis of rhinosinusitis
- indication for functional endoscopic sinus surgery
- American Society of Anesthesiologists risk score > 2
- undertreated hypertension
- Haemoglobin A1c test level > 7.5
- concurrent surgery
- history of drug abuse
- history of or new diagnosis of allergy to any of the study drugs
- history of post-operative nausea and vomiting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484859
|Recep Tayyip Erdogan University|
|Rize, Eastern Blacksea, Turkey, 53100|
|Principal Investigator:||Başar Erdivanlı, Asst. Prof.||Recep Tayyip Erdogan University, Medical Faculty, Department of Anesthesiology|
|Responsible Party:||Başar Erdivanlı, Asst. Prof., Rize Üniversitesi|
|Other Study ID Numbers:||
|First Posted:||June 30, 2015 Key Record Dates|
|Results First Posted:||September 10, 2019|
|Last Update Posted:||September 17, 2019|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||We are still evaluating the guideline of the Medical Research Council (MRC) Hubs for Trials Methodology Research (HTMR) for individual participant data sharing.|
Functional endoscopic sinus surgery
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Pathological Conditions, Anatomical
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
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Molecular Mechanisms of Pharmacological Action