Dexemedetomidine on Shivering Cesarean Section Under Spinal Anesthesia A Randomized Clinical Trial

• ClinicalTrials.gov Identifier: NCT05952752
• Recruitment Status: Not yet recruiting
• First Posted: July 19, 2023
• Last Update Posted: July 25, 2023
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ayman Abd El-Khalek Mohammed Glala, Assiut University

Study Description

Brief Summary:

Participants will examine dexemedetomidine versus dexamethasone on postoperative shivering after spinal anesthesia for caesarean section

Condition or disease	Intervention/treatment	Phase
Postoperative Shivering	Other: giving dexemedetomidine 12 microgram Iv dripping; Other: Dexamethsone IV	Not Applicable

Detailed Description:

Patients and Methods Setting and ethics and trial registration The present randomized clinical study is planned to be conducted at Gynecology and Obstetrics Department, Assiut University Hospitals in the time from February through March, 2023. The study protocol will be approved by the independent institutional review board and all participants with provide informed consent prior to enrollment. The study will be registered at clinicaltrials.gov before recruitment of the first patient. Sample size calculation To detect a 20 % of differences between shivering scores in the studies groups, the sample size was calculated using a study power of 95.0 % and two-sided significance level of 5.0 % with 1:1 ratio. The estimated sample size for each group was 164 patients. We added 10 % of patients as expected dropout rate. So, the final sample size will be 191 patients per group. Sample size was calculated using G Power 3.1.6.9 (Kiel University, Germany).

Patient recruitment The present study will include American Society of Anesthesiology (ASA) I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications.

Randomization, blinding and allocation Patients in each study category will be equally and randomly assigned to receive either DEXA or DEXM using computer generated random tables and sealed envelopes. Independent researchers who aren't aware of the scope of the study will be assigned to assess and report patient outcome. Used medications will be prepared in similar packages to secure adequate blinding.

Preoperative preparation, monitoring and anesthesia All patients will be instructed, prepared and monitored according the standard guidelines.

Preoperative medications will include IV granisetron 1gm and ranitidine 50mg. Spinal anesthesia will be accomplished using 10-12 mg of 0.5% hyperbaric bupivacaine. When adequate level of anesthesia is guaranteed, CS is started under appropriate hemodynamic monitoring. Once the baby is delivered, 10 IV units of oxytocin will be administered.

Study interventions Patients in the studied groups will receive either or intravenous DEXM 10 µg (Sween et al., 2021) or IV infusion of DEXA 8 mg (Esmat et al., 2021). Outcome assessment The primary outcome of the present study is the incidence of clinically significant postoperative shivering (Grade 2/3) assessed by 4-point scale (Badjatia et al., 2008) as follows:

1. None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall
2. Mild (Grade 1): shivering localized to the neck and/ or thorax only
3. Moderate (Grade 2): shivering involved gross movement of the upper extremities (in addition to neck and thorax)
4. Severe (Grade 3): shivering involved gross movements of the trunk and upper and lower extremities Secondary outcome measures will be postoperative pain, hypotension, sedation grade, patient satisfaction, time to sensory and motor onset and time to use of first rescue analgesia.

Statistical analysis All reported data will be recorded and statistically analyzed using appropriate statistical tests.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 382 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

The estimated sample size for each group was 164 patients. We added 10 % of patients as expected dropout rate. So, the final sample size will be 191 patients per group. Sample size was calculated using G Power 3.1.6.9 (Kiel University, Germany).

The present study will include American Society of Anesthesiology (ASA) I-II women scheduled for elective CS under intrathecal anesthesia. All patients will be instructed, prepared and monitored according the standard guidelines.

Preoperative medications will include IV granisetron 1gm and ranitidine 50mg. Spinal anesthesia will be accomplished using 10-12 mg of 0.5% hyperbaric bupivacaine. When adequate level of anesthesia is guaranteed, CS is started under appropriate hemodynamic monitoring. Once the baby is delivered, 10 IV units of oxytocin will be administered. Patients in the studied groups will receive either or intravenous DEXM 10 µg (Sween et al., 2021) or IV infusion of DEXA 8 mg (Esmat et al., 2021).

• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Patients in each study category will be equally and randomly assigned to receive either DEXA or DEXM using computer generated random tables and sealed envelopes. Independent researchers who aren't aware of the scope of the study will be assigned to assess and report patient outcome. Used medications will be prepared in similar packages to secure adequate blinding.
• Primary Purpose: Prevention
• Official Title: Effect of Dexamethasone Versus Dexmedetomidine on Postoperative Shivering After Cesarean Section Under Spinal Anesthesia
• Estimated Study Start Date: July 20, 2023
• Estimated Primary Completion Date: September 25, 2023
• Estimated Study Completion Date: October 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Dexamethsone; 4 mg will be given for this group IV	Other: Dexamethsone IV; 4 mg IV dexamethasone; Other Name: Dexamethasone
Experimental: Dexemedetomidine; 12 ug will be given IV infusion for this group	Other: giving dexemedetomidine 12 microgram Iv dripping; Patients in the studied groups will receive either or intravenous Dexemedetomidine 12 µg; Other Name: Dexemedetomidine

Outcome Measures

Primary Outcome Measures :

1. Prevention of postoperative shivering according to bedside shivering assessment scale [ Time Frame: till end of spinal anesthesia up to 6 hours ]
   • grade I: no shivering (score 0)
   • Grade II: localized to the neck or thorax mainly (score 1)
   • Grade III: moderate shivering including the gross length of upper extremeties(score2)
   • Grade IV:severe shivering including the gross movement of the trunk, upper and lower extremities( score 3)

Secondary Outcome Measures :

1. postoperative analgesia according to numerical rating scale( NRS) [ Time Frame: 6 hours after induction of spinal anesthesia ]
   NRS score assessment in combination to time to first rescue of analgesia including score 1 with the least pain experienced in life and score 10 as the most painful experienced pain in life then the pain grading is in between

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Female
• Pregnant full term
• Undergoing Cesarean section
• Spinal anesthesia

Exclusion Criteria:

• Patient refusal
• General anesthesia
• Contraindications for spinal anesthesia
• Obstetric hemorrhagic complications as placenta accreta, previa, concealed hemorrhage
• Hysterectomy

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Ayman Abd El-Khalek Mohammed Glala, principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05952752
• Other Study ID Numbers: dexemedetomidine on shivering
• First Posted: July 19, 2023
• Last Update Posted: July 25, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayman Abd El-Khalek Mohammed Glala, Assiut University:

Dexmedetomidine; Dexamethasone; Postoperative shivering; Shivering; Postoperative analgesia; PONV

Additional relevant MeSH terms:

Dexamethasone; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents