Caffeine and Neurologic Recovery Following Surgery and General Anesthesia

University of Michigan

Status and phase: Completed; Early Phase 1

Conditions: Pain, Postoperative

Treatments: Drug: Caffeine Citrate; Drug: Dextrose Water

Study type: Interventional

Funder types: Other

Identifiers

NCT03577730

HUM00135919

Details and patient eligibility

About

The ongoing opioid epidemic is a public health crisis, and surgical patients are particularly vulnerable to opioid-dependency and related risks. Emerging data suggest that caffeine may reduce pain after surgery. Thus, the purpose of this study is to test whether caffeine reduces pain and opioid requirements after surgery. The investigators will also test whether caffeine improves mood and brain function (e.g., learning, memory) after surgery.

Full description

Opioid-related deaths have quadrupled in the last 20 years, and nearly half of these deaths currently involve prescription opioids. Surgical patients often experience moderate-to-severe pain is common after major surgery, and surgery is associated with a 14-fold increased risk of opioid dependency compared to non-surgical controls, even after minor surgery. Furthermore, mood disorders (e.g., depression) are independently associated with persistent opioid use postoperatively, and signs of postoperative depression are common after major surgery. Thus, given these risk factors, surgical patients are at particularly high risk for opioid dependency postoperatively. Interventions that (1) reduce opioid burden, and (2) improve mood and neuropsychological function may mitigate the risk of postoperative opioid dependency. Preliminary laboratory and clinical findings demonstrate that caffeine may reduce pain after surgery, which may translate to lower opioid requirements. The study tests the hypothesis that intraoperative caffeine administration will improve opioid consumption, pain, and neuropsychological recovery in patients undergoing surgery. Through validated assessment measures, the research team will study the effects of caffeine in relation to postoperative opioid requirements, pain, and neuropsychological (e.g., cognition, depression, anxiety) trajectory after surgery.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (>/= 18 years old) undergoing non-cardiac, non-neurologic, non-major vascular surgery requiring general anesthesia

Exclusion criteria

• Emergency surgery
• Cognitive impairment precluding capacity for informed consent
• Uncontrolled cardiac arrhythmias
• Seizure disorders
• Preoperative opioid use
• Diabetes
• Liver failure
• Pregnancy
• Breastfeeding
• Severe visual or auditory impairment (may hinder cognitive function testing)
• Patients unable to speak English.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.

Treatment:

Drug: Caffeine Citrate

Control

Placebo Comparator group

Description:

Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.

Treatment:

Drug: Dextrose Water