Dexmedetomidine on Optic Nerve Sheath Diameter

Not Applicable

Withdrawn

• Conditions: Intracranial Hypertension
• Interventions: Drug: normal saline; Drug: Dexmedetomidine

• Registration Number: NCT02753205
• Lead Sponsor: Gachon University Gil Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-24
• Study First Posted: 2016-04-27
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-10
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	normal saline	Infusion of normal saline
Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter	Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min	mm

Secondary Outcome Measures

Name	Time	Method
Respiratory and mean arterial pressure	Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min	mmHg