Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery

NCT01194089 | Completed Phase 4 Results

• 1 other identifier: 10-002241
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double-blind study will enroll nonsmoking female subjects undergoing laparoscopic bariatric surgery under general anesthesia. The hypothesis of this study is that female nonsmokers who receive nicotine via nasal spray immediately before waking up from anesthesia will need less pain medications 24 hours after the surgery compared to the subjects who receive placebo spray.

Conditions

Pain, Postoperative

Keywords

Nicotine; Postoperative pain; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively

  Opioid use was calculated in intravenous morphine equivalents (iv MEQ) according to the Mayo Clinic Pharmacy opioid conversion calculator based on the recommendations from the American Pain Society. Specifically, the following conversion was used: 10 mg in MEQ=100mcg iv fentanyl=1.5 mg iv hydromorphone=20mg oral oxycodone=30mg oral hydrocodone.

  During PACU stay (approximately 94 minutes after operation), 24 hours after operation

Secondary Outcomes (2)

• Number of Participants Who Needed to Use Antiemetic Medication in the PACU

  24 hours postoperatively.

• Numeric Pain Score

  on admission, 30 minutes, 60 minutes, at discharge

Study Arms (2)

Nasal Nicotine Spray

ACTIVE COMPARATOR

3 mg of nasal nicotine will be administered postoperatively.

Drug: Nasal Nicotine Spray

Nasal Normal Saline Spray

PLACEBO COMPARATOR

1 ml of nasal normal saline spray will be administered postoperatively.

Drug: Nasal Normal Saline Spray

Interventions

Nasal Nicotine Spray DRUG

Single 3 mg dose of nasal nicotine spray

Also known as: Nicotrol NS

Nasal Nicotine Spray

Nasal Normal Saline Spray DRUG

An isotonic solution of sodium chloride 0.65% in deionized water

Also known as: Rhino-Mist, Salinex, Ocean Nasal Spray

Nasal Normal Saline Spray

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) class 2-3
• Non-smokers, defined as not smoking (not even a puff) for at least one year preoperatively, and having smoked less than 100 cigarettes throughout their life or remote history of smoking with complete tobacco abstinence (not even a puff) for at least 10 years
• Scheduled for elective laparoscopic bariatric surgery (other than gastric banding or sleeve resection bariatric surgeries as these are outpatient procedures) requiring general anesthesia.

You may not qualify if:

• Regular use of opioid medications in the past year, any prior use of sustained release opioid medications, or history of substance abuse with opioids
• History of previous psychiatric hospitalizations
• Allergy to nicotine
• Previous bariatric surgery or previous foregut surgery
• Pregnant or lactating female (per usual surgical routine)
• Contraindications for receiving ketorolac (elevated creatinine)
• Unstable angina, severe uncontrolled hypertension, serious cardiac dysrhythmias (tachyarrhythmias, atrial fibrillation), or vasospastic diseases (Buerger's disease, Raynaud's phenomena)
• Unable to provide informed consent to participate in the study
• Contraindication to the proposed antiemetics.

Sponsors & Collaborators

• Toby Weingarten: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Weingarten TN, McGlinch BP, Liedl L, Kendrick ML, Kellogg TA, Schroeder DR, Sprung J. Intranasal nicotine increases postoperative nausea and is ineffective in reducing pain following laparoscopic bariatric surgery in tobacco-Naive females: a randomized, double blind trial. Obes Surg. 2015 Mar;25(3):506-13. doi: 10.1007/s11695-014-1431-7.

  PMID: 25190522 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Toby N. Weingarten
• Organization: Mayo Clinic

weingarten.toby@mayo.edu

507-255-1612

Study Officials

• Toby Weingarten, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 9, 2015
• Results First Posted: June 3, 2015

Record last verified: 2015-06

Locations

US (1)