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

NCT05161780 | Completed Phase 1 FDA Drug

• 1 other identifier: STUDY21110081
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Irrigation

Outcome Measures

Primary Outcomes (4)

• Boezaart scale rating video clips

  Rating for each of the three recorded video clips per patient following tumor ablation. 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.

  10 minutes

• Boezaart scale rating video clips

  rating for each of the three recorded video clips per patient after 10 minutes of irrigation. 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.

  10 minutes

• Boezaart scale rating video clips

  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..

  10 minutes

• Time

  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.

  10 minutes

Secondary Outcomes (1)

• Estimated Blood Loss (EBL)

  15 min

Study Arms (2)

Normal Saline

ACTIVE COMPARATOR

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.

Drug: Normal Saline

Lactated Ringer's Irrigation

EXPERIMENTAL

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.

Drug: Lactated Ringer's Irrigation

Interventions

Lactated Ringer's Irrigation DRUG

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.

Lactated Ringer's Irrigation

Normal Saline DRUG

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.

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Carl Snyderman: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Carl Snyderman, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The surgeon will be blinded to the type of irrigation being used
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 17, 2021
• Study Start: February 9, 2022
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)