IV Dexamethasone for Spinal Anesthesia

Overseen By Kwesi Kwofie, MD FRCPC

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: IWK Health Centre

Must not be taking: Chronic steroids, NSAIDs

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

192 Participants Needed

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}

Research Team

Allana Munro, MD FRCPC

Principal Investigator

IWK Health

Kwesi Kwofie, MD FRCPC

Principal Investigator

IWK Health

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 scheduled for a C-section with spinal anesthesia.

Term gestational age (≥37 weeks)

Singleton pregnancy

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

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
• Metoclopramide

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

Who Is Running the Clinical Trial?

IWK Health Centre

Lead Sponsor

Trials

131

Recruited

112,000+

Findings from Research

In a study of 180 patients undergoing elective surgeries with spinal anesthesia, both diabetic and nondiabetic patients experienced a significant increase in blood glucose levels after receiving low doses of dexamethasone (4 mg and 8 mg).

The maximum rise in blood glucose was similar for both groups, reaching about 40-45 mg/dL, indicating that clinicians should carefully consider the potential for hyperglycemia when administering dexamethasone for preventing postoperative nausea and vomiting.

NCBI (Pubmed)

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. Purushothaman, AM., Pujari, VS., Kadirehally, NB., et al.[2022]

In a study of 100 female patients undergoing spinal surgery, the combination of ramosetron and dexamethasone significantly reduced the incidence of moderate to severe nausea and vomiting compared to ramosetron alone, indicating improved management of postoperative nausea and vomiting (PONV).

Patients receiving the combination treatment experienced fewer episodes of vomiting (5 vs. 13) and moderate to severe nausea (10 vs. 20), suggesting that adding dexamethasone enhances the efficacy of ramosetron in preventing PONV in those at high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery. Yang, SY., Jun, NH., Choi, YS., et al.[2022]

In a study of 44 patients undergoing unilateral inguinal herniorrhaphy, adding dexamethasone to epidural bupivacaine significantly accelerated the onset of sensory block and prolonged postoperative analgesia compared to bupivacaine alone.

The addition of dexamethasone also reduced the incidence of nausea, with only 22.7% of the control group experiencing nausea in the first hour post-procedure, while none in the dexamethasone group reported nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural Dexamethasone for Postoperative Analgesia in Patients Undergoing Unilateral Inguinal Herniorrhaphy: A Comparative Study. Razavizadeh, MR., Fazel, MR., Heydarian, N., et al.[2018]

In a study involving 60 patients undergoing inguinal herniorrhaphy, a single dose of 10 mg dexamethasone did not improve pain relief or reduce the incidence of postoperative nausea and vomiting (PONV) after spinal anesthesia with tetracaine and neostigmine.

The findings suggest that dexamethasone does not enhance the analgesic effects of neostigmine or decrease the severity of nausea and vomiting following intrathecal administration, indicating it may not be beneficial in this specific postoperative context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dexamethasone on postoperative pain and emesis after intrathecal neostigmine. Tan, PH., Liu, K., Peng, CH., et al.[2022]

Intravenous dexamethasone significantly delayed the regression of hyperbaric bupivacaine spinal anesthesia, leading to longer sensory and motor block durations in 200 patients undergoing lower abdominal surgery.

Patients receiving dexamethasone experienced a longer time until their first postoperative analgesic request and reported lower pain scores, suggesting it can effectively reduce overall analgesic consumption post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. Abdel-Wahab, AH., Abd Alla, ES., Abd El-Azeem, T.[2023]

In a study of 30 obese patients with impaired glucose tolerance undergoing gastric bypass surgery, those who received 8 mg of dexamethasone showed significantly higher blood glucose levels compared to a control group receiving saline, particularly from 6 to 12 hours post-surgery.

The maximum blood glucose level in the dexamethasone group was 10.4 mmol/L, which was notably higher than the 8.8 mmol/L observed in the control group, indicating that dexamethasone can exacerbate hyperglycemia in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone for postoperative nausea and vomiting prophylaxis: effect on glycaemia in obese patients with impaired glucose tolerance. Nazar, CE., Lacassie, HJ., López, RA., et al.[2022]

In a study of 18,872 hip and knee arthroplasties, a single low dose of dexamethasone (5-10 mg) did not increase the risk of post-operative prosthetic joint infections (PJIs), indicating its safety for use in these surgeries.

Dexamethasone effectively prevents post-operative nausea and vomiting (PONV) and may help reduce post-operative pain without raising infection rates, making it a beneficial option in multimodal pain management for arthroplasty patients.

NCBI (Pubmed)

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. Vuorinen, MA., Palanne, RA., Mäkinen, TJ., et al.[2020]

In a study of 178 patients undergoing lower extremity orthopedic surgery, intravenous dexamethasone did not significantly reduce the incidence of Post-Dural Puncture Headache (PDPH) compared to a placebo.

However, patients who received dexamethasone experienced less severe headaches, suggesting that it can effectively decrease the intensity of PDPH when given prophylactically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone in preventing post-dural puncture headache: a randomized, double-blind, placebo-controlled trial. Doroudian, MR., Norouzi, M., Esmailie, M., et al.[2022]

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]

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]

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

Epidural Dexamethasone for Postoperative Analgesia in Patients Undergoing Unilateral Inguinal Herniorrhaphy: A Comparative Study. [2018]

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

The effect of dexamethasone on postoperative pain and emesis after intrathecal neostigmine. [2022]

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]

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]

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]

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

Dexamethasone in preventing post-dural puncture headache: a randomized, double-blind, placebo-controlled trial. [2022]