IV Dexamethasone for Spinal Anesthesia

Recruiting in Palo Alto (17 mi)

Overseen by Allana Munro, MD FRCPC

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: IWK Health Centre

Must not be taking: Chronic steroids, NSAIDs

Disqualifiers: Obesity, Height < 5'0", others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the effects of intravenous (IV) dexamethasone on spinal anesthesia in healthy women having an elective Cesarean delivery (CD) at the IWK Health Centre. The main questions it aims to answer are: 1. What effect does IV dexamethasone have on the resolution of motor blockade in patients having spinal anesthesia for elective CDs? 2. What effect does IV dexamethasone have on the sensory recovery of spinal blockade, the total hydromorphone requirement in the first 24 h postoperatively, the incidence of pruritis perioperatively, and the incidence of nausea and vomiting? The spinal anesthesia technique will be standardized and will be administered as per routine care at IWK Health. Computer generation will randomize patients to either Group SD, who will receive IV dexamethasone, or group SM who will receive IV metoclopramide, an alternative anti-emetic, immediately after spinal anesthesia by the attending anesthesia provider. Each patient will receive ondansetron, a second anti- emetic as recommended for Enhanced Recovery After Surgery (ERAS) protocol. Participant sensation, pain, nausea, pruritus, and motor blockade will be assessed in recovery. The patient's sensation and Bromage score will be assessed every 15 minutes until sensation is reached at L3 and a Bromage score of 4 is achieved. The investigators will determine if there is a difference between groups regarding motor blockade, the length of time of spinal anesthesia, and side effects after CD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use chronic steroids, you cannot participate in this trial.

What data supports the effectiveness of the drug dexamethasone for spinal anesthesia?

Research shows that dexamethasone can help prevent nausea and vomiting after surgery, which is a common issue with spinal anesthesia. Additionally, when added to other anesthetics, dexamethasone can prolong the duration of pain relief after surgery. ^{1 2 3 4 5}

Is IV Dexamethasone safe for use in humans?

Dexamethasone is generally safe for use in humans, but it can cause an increase in blood sugar levels, especially in people with diabetes or impaired glucose tolerance. It has been used to prevent nausea and vomiting after surgery and does not seem to increase the risk of infection in large surgeries like hip and knee replacements. ^{1 3 4 6 7}

How does the drug dexamethasone differ from other treatments for spinal anesthesia?

Intravenous dexamethasone is unique in its ability to potentially prolong the duration of spinal anesthesia and reduce the severity of post-dural puncture headaches, which are common complications of spinal anesthesia. This makes it different from other treatments that may not address these specific issues. ^{1 3 4 5 8}

Eligibility Criteria

This trial is for healthy women over 18, with a single baby at term (≥37 weeks), planning a non-emergency Cesarean delivery using spinal anesthesia. They should speak moderate English and have an ASA physical status class < III. Excluded are those with contraindications to spinal analgesia, abnormal spine anatomy, significant health issues, height under 5'0", chronic steroid use, NSAID intolerance, opioid sensitivity or tolerance, and severe obesity (BMI ≥45kg/m2).

Inclusion Criteria

I am 18 years old or older.

I am scheduled for a C-section with spinal anesthesia.

Term gestational age (≥37 weeks)

Exclusion Criteria

I cannot have spinal or epidural pain relief due to a bleeding disorder, infection, or nerve disease.

I am tolerant or sensitive to opioids.

A physical or psychiatric condition which impairs cooperation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal anesthesia and are randomized to receive either IV dexamethasone or IV metoclopramide immediately after spinal anesthesia

1 day

1 visit (in-person)

Post-Anesthesia Recovery

Participants are monitored in the PACU for motor and sensory recovery, pain, nausea, and other side effects

Until Bromage score of 4 is achieved

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid use and side effects

24 hours

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)
• Metoclopramide (Other)

Trial Overview The study tests if IV dexamethasone affects the duration of motor and sensory blockade from spinal anesthesia in elective Cesarean deliveries compared to IV metoclopramide. Women will be randomly assigned to receive either dexamethasone or metoclopramide after their anesthesia. Recovery assessments include sensation level checks every 15 minutes until specific recovery criteria are met.

Participant Groups

Group I: Dexamethasone (Group SD) Experimental Treatment 1 Intervention

10 mg IV dexamethasone x1

Group II: Metoclopramide (Group SM) Active Control 1 Intervention

10 mg IV metoclopramide x1

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

IWK Health Centre Halifax, Canada

Who Is Running the Clinical Trial?

IWK Health Centre Lead Sponsor

References

1. India pubmed.ncbi.nlm.nih.gov

A prospective randomized study on the impact of low-dose dexamethasone on perioperative blood glucose concentrations in diabetics and nondiabetics. [2022] Dexamethasone is a potent corticosteroid when administered alone or in combination alone has proven efficacious in preventing nausea and vomiting (PONV) perioperatively. However, the administration of even a single dose has been associated with hyperglycemia. This is the first study that evaluates the effect of two low-doses of dexamethasone (4 and 8 mg) on blood glucose concentrations among diabetics and nondiabetics in patients who have received spinal anesthesia.

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery. [2022] Opioid-based patient controlled analgesia (PCA) provides adequate pain control following spinal surgeries at the expense of increased risk of postoperative nausea and vomiting (PONV). We evaluated the efficacy of dexamethasone added to ramosetron, which is a newly developed five-hydroxytryptamine receptor 3 antagonist with a higher receptor affinity and longer action duration compared to its congeners, on preventing PONV in highly susceptible patients receiving opioid-based IV PCA after spinal surgery.

3. United States pubmed.ncbi.nlm.nih.gov

Epidural Dexamethasone for Postoperative Analgesia in Patients Undergoing Unilateral Inguinal Herniorrhaphy: A Comparative Study. [2018] Background. This study was designed to evaluate the effect of adding dexamethasone to epidural bupivacaine on postoperative analgesia in unilateral inguinal herniorrhaphy. Methods. Forty-four patients were enrolled in this double-blind, clinical trial study. Patients were randomly allocated into dexamethasone or control group. In the dexamethasone group, patients received 18&#8201;ml of bupivacaine 0.5% and 2&#8201;ml (8&#8201;mg) of dexamethasone; in the control group, patients received 18&#8201;ml of bupivacaine 0.5% and 2&#8201;ml of normal saline. The onset of sensory block and its duration and incidence of nausea and vomiting were recorded. Results. The onset of epidural anesthesia was significantly more rapid in the dexamethasone group than in the control group (P &lt; 0.001). Duration of analgesia was markedly prolonged in the dexamethasone group than in the control group (P &lt; 0.001). Five patients (22.7%) in the control group had nausea in the first hour after the procedure (P = 0.048). None of the patients in the dexamethasone group had nausea. None of our patients had vomiting in the two groups. Conclusions. This study showed that adding dexamethasone to bupivacaine significantly prolongs the duration of postoperative analgesia. This trial is registered with Iranian Registry of Clinical Trials (IRCT) number IRCT2012062910137N1.

4. United States pubmed.ncbi.nlm.nih.gov

The effect of dexamethasone on postoperative pain and emesis after intrathecal neostigmine. [2022] We evaluated the effect of a single dose of dexamethasone on the incidence and severity of postoperative nausea and vomiting (PONV) after intrathecal injection of tetracaine plus neostigmine. Sixty ASA physical status I patients scheduled for inguinal herniorrhaphy were studied with a randomized, double-blinded, placebo-controlled protocol. The dexamethasone group (Group D) received 10 mg of dexamethasone IV before performance of spinal anesthesia, whereas the placebo group (Group P) received saline. Spinal anesthesia was performed with intrathecal injection of 15 mg tetracaine plus neostigmine 100 microg in both groups. Pain, PONV, and other side effects were evaluated 24 h after surgery. The duration and severity of analgesia and the incidence of PONV were not significantly different between the two groups. Our results demonstrate that a single dose of dexamethasone (10 mg) did not potentiate the analgesic effect or reduce the incidence of PONV after intrathecal injection of tetracaine and neostigmine.

5. England pubmed.ncbi.nlm.nih.gov

Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. [2023] The purpose of this study was to investigate the effect of intravenous (IV) dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia.

6. England pubmed.ncbi.nlm.nih.gov

Dexamethasone for postoperative nausea and vomiting prophylaxis: effect on glycaemia in obese patients with impaired glucose tolerance. [2022] Dexamethasone given to prevent postoperative nausea and vomiting may produce significant hyperglycaemia in the perioperative period. The effect of dexamethasone on patients with impaired glucose tolerance is unknown.

7. Germany pubmed.ncbi.nlm.nih.gov

Infection safety of dexamethasone in total hip and total knee arthroplasty: a study of eighteen thousand, eight hundred and seventy two operations. [2020] Dexamethasone has been shown to prevent post-operative nausea and vomiting (PONV) and seems to reduce post-operative pain. Both factors, which can extend the hospital stay, delay rehabilitation, and impact patient satisfaction. Because of the immunosuppressive and glucose-rising effects of dexamethasone, there has been concern of its safety in arthroplasty surgery. The purpose of our study was to examine infection safety of dexamethasone in arthroplasty surgery with enough large study material to reliably detect a possible, even small, difference in infection incidence.

8. Belgium pubmed.ncbi.nlm.nih.gov

Dexamethasone in preventing post-dural puncture headache: a randomized, double-blind, placebo-controlled trial. [2022] Spinal anesthesia is major complication is Post-Dural Puncture Headache (PDPH) which is an intense and debilitating event. We decided to assess if intravenous administration of dexamethasone can decrease the incidence and/or intensity of this kind of headache. For this purpose 178 patients, who were supposed to undergo lower extremity orthopedic surgery, were enrolled in the study . Before spinal anesthesia was initiated, the first group (DXM-group) received 2 mL intravenous (i.v) dexamethasone whereas the second group (PCB-group) received 2 mL i.v. normal saline. After termination of surgery, a 7 days follow-up started to observe the possible occurrence and intensity of PDPH. There was no statistically significant difference between DMX and PCB groups regarding the incidence of PDPH. However, the intensity of headache differed between the two groups being less severe if IV dexamethasone had been given prophylactically. Dexamethasone can be used to decrease the severity of PDPH in patients who receive spinal anesthesia.