NCT05161780

Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Carl Snyderman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine whether Normal Saline or Lactated Ringer's irrigation is superior in maintaining superior endoscopic surgical field clarity in surgery for pituitary adenoma.

Detailed description

The aims of this study are to determine whether the endoscopic surgical view is objectively clearer using Normal Saline versus Lactated Ringer's Irrigation during endoscopic skull base surgery for pituitary adenoma. Other objectives include determining whether lactated Ringer's irrigation decreases total estimated blood loss and whether use of lactated Ringer's irrigation shortens surgical time. Hot saline irrigation at 40 degrees Celcius has been shown to improve endoscopic surgical field clarity and its use is common practice in both endoscopic inflammatory sinus surgeries and skull base procedures. Saline irrigation dilutes blood in the surgical field keeping the endoscopic view clean and more bloodless and the elevated temperature promotes hemostasis. Preliminary evidence suggests that the use of calcium-containing irrigant may further improve endoscopic surgical views. This mechanism is thought to be mediated through the activation of platelets and providing a calcium source to calcium-dependent factors in the coagulation cascade thereby promoting hemostasis. Using lactated Ringer's, a calcium-containing fluid, may result in improved surgeon visualization, decreased blood loss, and decreased complications during endoscopic approaches to the skull base.

Conditions

• Irrigation

Interventions

Type	Name	Description
DRUG	Lactated Ringer's Irrigation	Lactated Ringers at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale.
DRUG	Normal Saline	Normal Saline at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale.

Timeline

• Start date: 2022-02-09
• Primary completion: 2024-06-13
• Completion: 2024-06-13
• First posted: 2021-12-17
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study