Dexmedetomidine on Optic Nerve Sheath Diameter

Intracranial Hypertension Clinical Trial

Official title:

Effect of Dexmedetomidine on Optic Nerve Sheath Diameter During Laparoscopic Anterior Resection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02753205
• Other study ID #: GCIRB2016-058
• Status: Withdrawn
• Phase: N/A
• First received: April 14, 2016
• Last updated: November 8, 2016
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: November 2016
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.

Description:

Laparoscopic lower abdominal surgery requires the Trendelenburg position with pneumoperitoneum for a prolonged time, but this can cause significant increase in intracranial pressure. Dexmedetomidine, a selective alpha2 receptor agonist might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of colorectal cancer

• planed for laparoscopic low anterior resection

Exclusion Criteria:

• morbid obesity (body mass index > 30 kg.m-2)

• history of cerebrovascular disease

• history of respiratory disease

• uncontrolled cardiovascular disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intracranial Hypertension

Intervention

Drug:
• Dexmedetomidine
infusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery
• normal saline
infusion of normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic nerve sheath diameter	mm	Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min	Yes
Secondary	Respiratory and mean arterial pressure	mmHg	Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min	Yes