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

Carl Snyderman

Status and phase: Completed; Phase 1

Conditions: Irrigation

Treatments: Drug: Normal Saline; Drug: Lactated Ringer's Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05161780

STUDY21110081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

47 participants in 2 patient groups

Normal Saline

Active Comparator group

Description:

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.

Treatment:

Drug: Normal Saline

Lactated Ringer's Irrigation

Experimental group

Description:

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.

Treatment:

Drug: Lactated Ringer's Irrigation