Clinical trial NCT05161780: Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation
Official title: Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irrigation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants will consist of 30 patients undergoing skull base surgery for a Pituitary Adenoma. This study will be a prospective double blinded randomized controlled trial examining the efficacy of normal saline versus Lactated Ringer's in achieving clarity of the surgical field during endoscopic skull base surgery.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Any patient with a primary pituitary adenoma, macro or micro adenoma.

Exclusion Criteria:

* Age \<18
* Pregnancy
* Revision surgery
* Non-surgical candidate due to medical, surgical, or anesthesia contraindications

Primary outcomes:
measure: Boezaart scale rating video clips
timeFrame: 10 minutes
measure: Boezaart scale rating video clips
timeFrame: 10 minutes
measure: Boezaart scale rating video clips
timeFrame: 10 minutes
measure: Time
timeFrame: 10 minutes
Secondary outcomes:
measure: Estimated Blood Loss (EBL)
timeFrame: 15 min
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Carl Snyderman, MD
role: PRINCIPAL_INVESTIGATOR
References: