Trial · NCT02484859
Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery
NCT02484859, Phase 4, Completed, Recep Tayyip Erdogan University; results first posted 2019-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery. Trials, record NCT02484859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02484859
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery
- NCT number
- NCT02484859
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 88 participants, actual
- Lead sponsor
- Recep Tayyip Erdogan University
- Conditions
- Nasal Polyps
- Interventions
- Remifentanil, Tramadol, Metoprolol
- First posted
- 2015-06-30
- Last updated
- 2023-12-20
- Results first posted
- 2019-09-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraoperative Bleeding Score | 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. 1. Slight bleeding, no suction is required. 2. Slight bleeding, occasional suctioning required. 3. Slight bleeding, frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. 4. Moderate bleeding, frequent suctioning required. Bleeding threatens surgical field as soon as suction is removed. 5. 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. |
| Secondary | Time to Achieve Intraoperative Bleeding Score < 3 | 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. |
| Secondary | Bleeding Rate | 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). |
| Secondary | Postoperative Pain | 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. |
| Secondary | Number of Participants With Postoperative Nausea and Vomiting | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraoperative Bleeding Score | throughout surgery, up to 3 hours | units on a scale | MEDIAN | |
| SECONDARY | Time to Achieve Intraoperative Bleeding Score < 3 | throughout surgery, up to 20 minutes | minutes | MEAN | |
| SECONDARY | Bleeding Rate | throughout surgery, up to 3 hours | ml/min | MEAN | |
| SECONDARY | Postoperative Pain | following extubation, up to 24 hours | units on a scale | MEDIAN | |
| SECONDARY | Number of Participants With Postoperative Nausea and Vomiting | following extubation, up to 24 hours | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraoperative Bleeding Score | Remifentanil | 1 | Inter-Quartile Range 1 to 1 | units on a scale | |
| Intraoperative Bleeding Score | Tramadol + Metoprolol | 1 | Inter-Quartile Range 1 to 1 | units on a scale | |
| Time to Achieve Intraoperative Bleeding Score < 3 | Remifentanil | 8.3 | Standard Deviation 2.1 | minutes | |
| Time to Achieve Intraoperative Bleeding Score < 3 | Tramadol + Metoprolol | 13.4 | Standard Deviation 4.2 | minutes | |
| Bleeding Rate | Remifentanil | 0.53 | Standard Deviation 0.2 | ml/min | |
| Bleeding Rate | Tramadol + Metoprolol | 0.45 | Standard Deviation 0.15 | ml/min | |
| Postoperative Pain | Remifentanil | VAS at arrival to PACU | 3 | Inter-Quartile Range 2 to 6 | units on a scale |
| Postoperative Pain | Tramadol + Metoprolol | VAS at arrival to PACU | 3 | Inter-Quartile Range 2 to 3 | units on a scale |
| Postoperative Pain | Remifentanil | VAS at discharge from PACU | 4 | Inter-Quartile Range 3 to 5 | units on a scale |
| Postoperative Pain | Tramadol + Metoprolol | VAS at discharge from PACU | 4 | Inter-Quartile Range 3 to 5 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Remifentanil | 44 | |
| Overall Study | STARTED | Tramadol + Metoprolol | 44 | |
| Overall Study | COMPLETED | Remifentanil | 44 | |
| Overall Study | COMPLETED | Tramadol + Metoprolol | 44 | |
| Overall Study | NOT COMPLETED | Remifentanil | 0 | |
| Overall Study | NOT COMPLETED | Tramadol + Metoprolol | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Adverse hemodynamic event in the surgical ward | Cardiac disorders | Remifentanil | 0 | 44 | 0 |
| other | Adverse hemodynamic event in the surgical ward | Cardiac disorders | Tramadol + Metoprolol | 0 | 44 | 0 |
| serious | Intraoperative hypotension | Cardiac disorders | Remifentanil | 3 | 44 | 8 |
| serious | Intraoperative hypotension | Cardiac disorders | Tramadol + Metoprolol | 0 | 44 | 0 |
| serious | Intraoperative bradycardia | Cardiac disorders | Remifentanil | 18 | 44 | 44 |
| serious | Intraoperative bradycardia | Cardiac disorders | Tramadol + Metoprolol | 0 | 44 | 0 |
| serious | Intraoperative bleeding | Blood and lymphatic system disorders | Remifentanil | 0 | 44 | 0 |
| serious | Intraoperative bleeding | Blood and lymphatic system disorders | Tramadol + Metoprolol | 0 | 44 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Remifentanil | ||
| Total, all-cause mortality | Tramadol + Metoprolol | ||
| Total, other adverse events | Remifentanil | 0 | 44 |
| Total, other adverse events | Tramadol + Metoprolol | 0 | 44 |
| Total, serious adverse events | Remifentanil | 21 | 44 |
| Total, serious adverse events | Tramadol + Metoprolol | 0 | 44 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Remifentanil vs Tramadol + Metoprolol: Number of Participants With Postoperative Nausea and Vomiting | Trial comparisons |
| Remifentanil vs Tramadol + Metoprolol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02484859
GET https://conductscience.org/api/trials/v1/NCT02484859/registered