Impact of Intrathecal vs Intravenous Dexmedetomidine

NCT06410365 | Not Yet Recruiting Phase 4

• 1 other identifier: WM&DCR/R&D(ERB)/2023/64
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research is to evaluate the impact of intrathecal dexmedetomidine in comparison with intravenous route in patients undergoing cesarean section. Alternate hypothesis :Dexmedetomidine is more effective when given intrathecally as adjuvant to bupivacaine in elective cesarean section Null Hypothesis: Dexmedetomidine is more effective when given intravenously as adjuvant to bupivacaine in elective cesarean section Study Design: Randomized controlled trial Study setting: Watim General Hospital Study Duration: 18 months after synopsis approval Sampling technique: Simple random sampling Sample Size: Using the Open Epi program, a sample size of 60 patients (30 in each group) was determined with a 95% confidence interval and 80% power. Inclusion Criteria:

• Pregnant women between ages 18-35 years
• Belongs to ASA class I or II
• Subjected to elective C-section Exclusion Criteria:
• Any history of gastrointestinal disease diabetes, thyroid disease, hypertension, obesity, or anemia
• History of alcohol or drug abuse;
• Major complications of pregnancy
• Patients have contraindication to spinal block or allergic to any of drug

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of clinical efficacy of intrathecal versus intravenous dexmedetomidine on intraoperative nausea vomiting,shivering and postoperative pain

  Intraoperative nausea and vomiting will be assessed using a a 4-point scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe) Postoperative pain will measured using a numeric pain rating scale (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain) every 30 minutes in the postoperative care

  during cesarean section surgery

Study Arms (2)

intrathecal dexmedetomidine+ bupivacaine

EXPERIMENTAL

intrathecal bupivacaine 0.75%(1.2ml+plus 5 μg Dex (diluted in N/S up to the volume of 1 ml intrathecally once

Drug: Dexmedetomidine injection

intravenous dexmedetomidine+ bupivacane

EXPERIMENTAL

intravenous dexmedetomidine 1mcg/kg in normal saline + intrathecal .75% bupivacaine (1.2ml)

Drug: Dexmedetomidine injection

Interventions

Dexmedetomidine injection DRUG

Comparison of intravenous and intrathecal route of dexmedetomidine

Also known as: Bupivacaine

intrathecal dexmedetomidine+ bupivacaine; intravenous dexmedetomidine+ bupivacane

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between ages 18-35 years
• Belongs to ASA class I or II
• Subjected to elective C-section

You may not qualify if:

• Any history of gastrointestinal disease diabetes, thyroid disease, hypertension, obesity, or anaemia
• History of alcohol or drug abuse;
• Major complications of pregnancy
• Patients have contraindication to spinal block or allergic to any of drug

Sponsors & Collaborators

• Muhammad Ilyas: lead

Related Publications (8)

• Semiz A, Akpak YK, Yilanlioglu NC, Babacan A, Gonen G, Cam Gonen C, Asiliskender M, Karakucuk S. Prediction of intraoperative nausea and vomiting in caesarean delivery under regional anaesthesia. J Int Med Res. 2017 Feb;45(1):332-339. doi: 10.1177/0300060516680547. Epub 2017 Jan 17.

  PMID: 28222642 BACKGROUND

• Harris PH. General versus spinal anaesthesia. Br Med J (Clin Res Ed). 1985 Apr 27;290(6477):1286. doi: 10.1136/bmj.290.6477.1286-a. No abstract available.

  PMID: 3921186 BACKGROUND

• Miao S, Shi M, Zou L, Wang G. Effect of intrathecal dexmedetomidine on preventing shivering in cesarean section after spinal anesthesia: a meta-analysis and trial sequential analysis. Drug Des Devel Ther. 2018 Nov 2;12:3775-3783. doi: 10.2147/DDDT.S178665. eCollection 2018.

  PMID: 30464408 BACKGROUND

• Bi YH, Wu JM, Zhang YZ, Zhang RQ. Effect of Different Doses of Intrathecal Dexmedetomidine as an Adjuvant Combined With Hyperbaric Ropivacaine in Patients Undergoing Cesarean Section. Front Pharmacol. 2020 Mar 20;11:342. doi: 10.3389/fphar.2020.00342. eCollection 2020.

  PMID: 32265713 BACKGROUND

• Rasooli S, Moslemi F, Khaki A. Effect of Sub hypnotic Doses of Propofol and Midazolam for Nausea and Vomiting During Spinal Anesthesia for Cesarean Section. Anesth Pain Med. 2014 Sep 16;4(4):e19384. doi: 10.5812/aapm.19384. eCollection 2014 Oct.

  PMID: 25346896 BACKGROUND

• Gouveia F, Oliveira C, Losa N. Acupuncture in the Management of Intraoperative Nausea and Vomiting. J Acupunct Meridian Stud. 2016 Dec;9(6):325-329. doi: 10.1016/j.jams.2016.09.005. Epub 2016 Sep 17.

  PMID: 28010836 BACKGROUND

• Dewinter G, Staelens W, Veef E, Teunkens A, Van de Velde M, Rex S. Simplified algorithm for the prevention of postoperative nausea and vomiting: a before-and-after study. Br J Anaesth. 2018 Jan;120(1):156-163. doi: 10.1016/j.bja.2017.08.003. Epub 2017 Nov 23.

  PMID: 29397124 BACKGROUND

• Shoar S, Esmaeili S, Safari S. Pain management after surgery: a brief review. Anesth Pain Med. 2012 Winter;1(3):184-6. doi: 10.5812/kowsar.22287523.3443. Epub 2012 Jan 1.

  PMID: 24904790 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Sadia Lodhi, MBBS,MPhil

CONTACT

00923345101061; drsadiajunaid07@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 13, 2024
• Study Start: June 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months after completion of study