Prostate Cancer Clinical Trial
Official title:
Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy: Comparison of Sevoflurane-remifentanil and Sevoflurane-remifentanil-dexmedetomidine
| NCT number | NCT03529643 |
| Other study ID # | 20180523 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 24, 2018 |
| Est. completion date | August 22, 2018 |
| Verified date | September 2018 |
| Source | Asan Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to evaluate the effect of anesthetic method on the optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.
| Status | Completed |
| Enrollment | 128 |
| Est. completion date | August 22, 2018 |
| Est. primary completion date | August 16, 2018 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 20 Years to 79 Years |
| Eligibility |
Inclusion Criteria: - Undergone a robot-assisted laparoscopic prostatectomy with a prostate - cancer - 20 years of age or older and under 80 years of age - Agree to participate in this study Exclusion Criteria: - History of cerebral hemorrhage or cerebral infarction - < 20 years of age - = 80 years of age - Glaucoma - Unexpected hemodynamic instability during surgery - Failure to measure optic nerve sheath diameter - Convert to open surgery |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Asan medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Asan Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in optic nerve sheath diameter | Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy | 60 minutes after pneumoperitoneum and steep Trendelenburg position | |
| Secondary | Difference in optic nerve sheath diameter | Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy. | 30 minutes after pneumoperitoneum and steep Trendelenburg position | |
| Secondary | Difference in optic nerve sheath diameter | Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy | 10 minutes after anesthesia induction | |
| Secondary | Difference in optic nerve sheath diameter | Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy | At skin closure |
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