Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation
- Conditions
- Irrigation
- Interventions
- Drug: Normal SalineDrug: Lactated Ringer's Irrigation
- Registration Number
- NCT05161780
- Lead Sponsor
- Carl Snyderman
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Any patient with a primary pituitary adenoma, macro or micro adenoma.
- Age <18
- Pregnancy
- Revision surgery
- Non-surgical candidate due to medical, surgical, or anesthesia contraindications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Normal Saline Normal Saline This study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the normal saline group using a random number generator. Lactated Ringer's Irrigation Lactated Ringer's Irrigation This study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the lactated reinger group using a random number generator.
- Primary Outcome Measures
Name Time Method Boezaart scale rating video clips 10 minutes rating for each of the three recorded video clips per patient at the completion of hemostasis. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection..
Time 10 minutes Time between tumor ablation and the completion of hemostasis, or total irrigation time for patients undergoing normal saline or Lactated Ringer's irrigation during their surgical case.
- Secondary Outcome Measures
Name Time Method Estimated Blood Loss (EBL) 15 min (EBL) per case and total operative time
Trial Locations
- Locations (1)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States