Peri-operative Shivering Under Spinal AnaesthesiaNCT07543913
Comparison of Two Drugs ,i.e., Nalbuphine Vs Ketamine at Low Doses for the Peri-Operative Shivering Control in Patients Undergoing Gynaecological Surgery Under Spinal Anaesthesia
A study testing Participants assigned to this arm received injection nalbuphine. and Participants assigned to this arm received injection ketamine. in people with Peri-operative Shivering Under Spinal Anaesthesia, run by Sargodha Medical College at 1 site in Pakistan.
Trial summary
Shivering is recognized as an undesirable effect of spinal anesthesia. Patients undergoing gynecological surgeries may experience increased physiological stress due to perioperative shivering. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Peri-operative Shivering Under Spinal Anaesthesia
- What is being tested?
- Participants assigned to this arm received injection nalbuphine. and Participants assigned to this arm received injection ketamine.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients of age between 18 and 40 years undergoing gynecological surgeries (total abdominal hysterectomy, ovarian cystectomy, vaginal hysterectomy, myomectomy).
- ASA 1 and 2.
Who cannot join
- ASA 3 and onwards as per the classification of the American Society of Anesthesiologists.
- Obstetric patients
- Patients who are allergic to study drugs.
- Patients undergoing general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Nalbuphin vs Ketamine for the Control of Peri-operative Shivering in Patients Undergoing Gynaecological Surgery Under Spinal Anaesthesia
Shivering is recognized as an undesirable effect of spinal anesthesia. Patients undergoing gynecological surgeries may experience increased physiological stress due to perioperative shivering. This condition can lead to serious complications such as increased oxygen consumption, resulting in hypoxemia, lactic acidosis, and elevated carbon dioxide production. Additionally, shivering may cause increased intraocular and intracerebral pressure and can interfere with monitoring techniques like pulse oximetry, blood pressure, and electrocardiography. If not treated, shivering can negatively impact patient outcomes, prolong recovery times, and extend hospital stays. The use of opioids has shown effectiveness in treating shivering. Based on the existing literature, it is hypothesized that there is no difference in the efficacy of nalbuphine and ketamine in controlling perioperative shivering in patients undergoing gynecological surgery under spinal anesthesia. Therefore, the study aims to investigate and compare the effectiveness of nalbuphine and ketamine in managing post-spinal shivering in these patients, focusing on i) incidence of shivering, ii) severity of shivering in both groups, iii) complications such as vomiting and sedation, and iv) the need for rescue medication. Preventing and managing shivering is crucial for successful surgical outcomes. To date, no comparative study has evaluated the intravenous efficacy of these two drugs in this patient population for post-spinal shivering control. This will be a double-blind, randomized controlled trial conducted in the Anesthesiology Department at DHQ Teaching Hospital Sargodha. A total of 90 gynecological patients will be enrolled and divided equally into two groups: Group N receiving nalbuphine and Group K receiving ketamine. Parameters such as heart rate, systolic and diastolic blood pressure, temperature, oxygen saturation, incidence and grade of shivering, complications like sedation and vomiting, and the need for rescue medication will be recorded. The study may face limitations due to the lack of advanced monitoring equipment for assessing parameters like core body temperature at the study site. Evaluations of cognitive and psychomotor functions cannot be conducted due to resource constraints. The use of a non-probability convenience sampling method, while practical, may introduce bias. Additionally, precise blinding may not be achievable due to limited technical personnel, and financial constraints prevent increasing the sample size.
Read the detailed description
Shivering, a repetitive involuntary muscular activity, is the most common problem during and after spinal anesthesia. The spinal anesthesia not only causes vasodilation, resulting in rapid loss of heat, but it also causes redistribution of heat in the peripheral areas, resulting in hypothermia and, eventually, shivering. Although it does not result in death, complications can arise in patients with a history of cardiorespiratory diseases, endangering the patients' safety. These complications include hypoxemia with increased lactic acidosis and carbon dioxide, increased oxygen consumption, increased intraocular and intracerebral pressure resulting in aggravation of post-operative pain and increased surgical bleeding that interferes with pulse rate and ECG monitoring.
Various treatments are currently available to control shivering in patients following spinal anesthesia. These include both pharmacological and non-pharmacological methods. Non-pharmaceutical methods are effective but expensive. A variety of pharmacological methods for controlling post-spinal anesthesia shivering have been suggested, including ketamine and nalbuphine as well as many others that are inexpensive and easy to use. Ketamine, a competitive receptor antagonist of N-methyl D-aspartate (NMDA), is known to reduce regional anesthesia by 70% and postoperative shivering by impairing thermoregulatory controls. It causes vasoconstriction in patients at risk of hypothermia. Ketamine controls shivering through non-shivering thermogenesis, either through the β-adrenergic effect of norepinephrine or through the hypothalamus. Nalbuphine, a semi-synthetic "class B" opioid analgesic, has both K-agonist and µ-antagonist properties. It has a high affinity for K-opioid receptors in the central nervous system. In the hypothalamus, the temperature regulation threshold is lowered by it for vasoconstriction during shivering due to the presence of high-density a2 adeno-receptors. The anti-shivering effects of intravenous ketamine and nalbuphine are poorly understood. Therefore, a double-blind, placebo-controlled, randomized study has been designed to compare the potency and efficacy of ketamine with nalbuphine and investigate the possible control mechanisms in patients undergoing gynecological surgery receiving spinal anesthesia.
The objectives of this study are to investigate and compare the effects of nalbuphine and ketamine in patients undergoing spinal anesthesia for gynecological surgeries in terms of:
- Incidence of shivering in both study groups
- Determine the grades of shivering
- Complications of study drugs such as vomiting and sedation
- Need of Rescue drug (injection of Tramadol IV 0.5 mg/kg)
- Being tested
- Participants assigned to this arm received injection nalbuphine., Participants assigned to this arm received injection ketamine.
- Keywords
- Peri-operative shivering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants assigned to this arm received injection nalbuphine.Drug
Also called Group N
After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected in the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug Nalbuphin (0.07 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute.
Participants assigned to this arm received injection ketamine.Drug
Also called Group K
After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected into the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug ketamine (0.2 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute.
| Study group | Role | What they receive |
|---|---|---|
| Participants assigned to this arm received injection nalbuphine. | Experimental | After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected in the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug Nalbuphin (0.07 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute. Receives: Drug: Participants assigned to this arm received injection nalbuphine. |
| Participants assigned to this arm received injection Ketamine. | Experimental | After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected into the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug ketamine (0.2 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute. Receives: Drug: Participants assigned to this arm received injection ketamine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of shivering in both study groups
Shivering will be assessed by the presence or absence of shivering.
Measured: Within one hour post-spinal anesthesia.
Grades of shivering
Shivering will be assessed by Tsai and Chu, with the grade of shivering as follows:
Grade of shivering: clinical sign 0 No shivering
- Piloerection or peripheral vasoconstriction, but no visible shivering
- Muscular activity in only one muscle group
- Muscular activity in more than one muscle group, but not generalized
- Shivering involving the whole body
Measured: After spinal anesthesia, grades of shivering were assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Secondary outcomes (7)
Heart rate
Heart rate will be monitored by a pulse oximeter probe.
Measured: After spinal anesthesia, heart rate will be assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Oxygen Saturation
Oxygen saturation will be monitored with a pulse oximeter probe.
Measured: After spinal anesthesia, oxygen saturation was assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Systolic blood pressure
Systolic blood pressure was measured with non-invasive blood pressure cuff.
Measured: After spinal anesthesia, systolic blood pressure was assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Diastolic blood pressure
Diastolic blood pressure was assessed by non-invasive blood pressure cuff.
Measured: After spinal anesthesia, diastolic blood was assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Temperature
Temperature was assessed by forehead temperature probe.
Measured: After spinal anesthesia, temperature was assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Sedation
Sedation will be assessed by Ramsay sedation score as follows:
Sedation score Sedation level
- Patient is anxious and agitated or restless, or both
- Patient is cooperative, oriented and tranquil
- Patient responds to command only
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
- Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
- Patient exhibits no response
Measured: Sedation was assessed for 1 hour post spinal anaesthesia.
Vomiting
Vomiting will be assessed clinically.
Measured: Vomiting was assessed for one hour post spinal anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Apr 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-operative Shivering Under Spinal AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind randomized controlled trial was conducted on 90 patients aged 18 to 40 years undergoing gynecological surgery after written consent and randomly divided into two groups of 45 each: Group N received Nalbuphine, and Group K received Ketamine. Patients with co-morbidities were excluded. Baseline hemodynamic parameters were recorded. Spinal anesthesia will be administered at L3-L4 or L4-L5. A dose of 1.2 mL of 0.75% hyperbaric bupivacaine was injected. Motor and sensory blocks will be assessed with the Bromage scale and a cold test. Following spinal anesthesia, patients will receive either Nalbuphine (0.07 mg/kg) or Ketamine (0.2 mg/kg) intravenously. The drugs, prepared in coded syringes, will be administered by an anesthetist blinded to group assignment. Shivering and hemodynamic variables were recorded. Sedation will be assessed by the Ramsay Sedation Score. Vomiting will be clinically monitored. If shivering reaches grade 3 or above, a rescue drug is given.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sargodha Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madeeha Khalid, Sargodha Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543913
- Sponsor's protocol ID
- SMC-ANS-2025-007
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Your study is a single-center anesthesia comparison trial. There is no requirement to share individual participant data (IPD). Unless you have a formal data-sharing mechanism (repository, request process, timelines), selecting Yes will create extra mandatory fields.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nalbuphin vs Ketamine for the Control of Peri-operative Shivering in Patients Undergoing Gynaecological Surgery Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT07543913
- Acronym / sponsor ID
- SMC-ANS-2025-007
- Keywords
- Peri-operative shivering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sargodha Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shivering is recognized as an undesirable effect of spinal anesthesia. Patients undergoing gynecological surgeries may experience increased physiological stress due to perioperative shivering. This condition can lead to serious complications such as increased oxygen consumption, resulting in hypoxemia, lactic acidosis, and elevated carbon dioxide production. Additionally, shivering may cause increased intraocular and intracerebral pressure and can interfere with monitoring techniques like pulse oximetry, blood pressure, and electrocardiography. If not treated, shivering can negatively impact patient outcomes, prolong recovery times, and extend hospital stays. The use of opioids has shown effectiveness in treating shivering. Based on the existing literature, it is hypothesized that there is no difference in the efficacy of nalbuphine and ketamine in controlling perioperative shivering in patients undergoing gynecological surgery under spinal anesthesia. Therefore, the study aims to investigate and compare the effectiveness of nalbuphine and ketamine in managing post-spinal shivering in these patients, focusing on i) incidence of shivering, ii) severity of shivering in both groups, iii) complications such as vomiting and sedation, and iv) the need for rescue medication. Preventing and managing shivering is crucial for successful surgical outcomes. To date, no comparative study has evaluated the intravenous efficacy of these two drugs in this patient population for post-spinal shivering control. This will be a double-blind, randomized controlled trial conducted in the Anesthesiology Department at DHQ Teaching Hospital Sargodha. A total of 90 gynecological patients will be enrolled and divided equally into two groups: Group N receiving nalbuphine and Group K receiving ketamine. Parameters such as heart rate, systolic and diastolic blood pressure, temperature, oxygen saturation, incidence and grade of shivering, complications like sedation and vomiting, and the need for rescue medication will be recorded. The study may face limitations due to the lack of advanced monitoring equipment for assessing parameters like core body temperature at the study site. Evaluations of cognitive and psychomotor functions cannot be conducted due to resource constraints. The use of a non-probability convenience sampling method, while practical, may introduce bias. Additionally, precise blinding may not be achievable due to limited technical personnel, and financial constraints prevent increasing the sample size.
Detailed description
Shivering, a repetitive involuntary muscular activity, is the most common problem during and after spinal anesthesia. The spinal anesthesia not only causes vasodilation, resulting in rapid loss of heat, but it also causes redistribution of heat in the peripheral areas, resulting in hypothermia and, eventually, shivering. Although it does not result in death, complications can arise in patients with a history of cardiorespiratory diseases, endangering the patients' safety. These complications include hypoxemia with increased lactic acidosis and carbon dioxide, increased oxygen consumption, increased intraocular and intracerebral pressure resulting in aggravation of post-operative pain and increased surgical bleeding that interferes with pulse rate and ECG monitoring.
Various treatments are currently available to control shivering in patients following spinal anesthesia. These include both pharmacological and non-pharmacological methods. Non-pharmaceutical methods are effective but expensive. A variety of pharmacological methods for controlling post-spinal anesthesia shivering have been suggested, including ketamine and nalbuphine as well as many others that are inexpensive and easy to use. Ketamine, a competitive receptor antagonist of N-methyl D-aspartate (NMDA), is known to reduce regional anesthesia by 70% and postoperative shivering by impairing thermoregulatory controls. It causes vasoconstriction in patients at risk of hypothermia. Ketamine controls shivering through non-shivering thermogenesis, either through the β-adrenergic effect of norepinephrine or through the hypothalamus. Nalbuphine, a semi-synthetic "class B" opioid analgesic, has both K-agonist and µ-antagonist properties. It has a high affinity for K-opioid receptors in the central nervous system. In the hypothalamus, the temperature regulation threshold is lowered by it for vasoconstriction during shivering due to the presence of high-density a2 adeno-receptors. The anti-shivering effects of intravenous ketamine and nalbuphine are poorly understood. Therefore, a double-blind, placebo-controlled, randomized study has been designed to compare the potency and efficacy of ketamine with nalbuphine and investigate the possible control mechanisms in patients undergoing gynecological surgery receiving spinal anesthesia.
The objectives of this study are to investigate and compare the effects of nalbuphine and ketamine in patients undergoing spinal anesthesia for gynecological surgeries in terms of:
- Incidence of shivering in both study groups
- Determine the grades of shivering
- Complications of study drugs such as vomiting and sedation
- Need of Rescue drug (injection of Tramadol IV 0.5 mg/kg)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind randomized controlled trial was conducted on 90 patients aged 18 to 40 years undergoing gynecological surgery after written consent and randomly divided into two groups of 45 each: Group N received Nalbuphine, and Group K received Ketamine. Patients with co-morbidities were excluded. Baseline hemodynamic parameters were recorded. Spinal anesthesia will be administered at L3-L4 or L4-L5. A dose of 1.2 mL of 0.75% hyperbaric bupivacaine was injected. Motor and sensory blocks will be assessed with the Bromage scale and a cold test. Following spinal anesthesia, patients will receive either Nalbuphine (0.07 mg/kg) or Ketamine (0.2 mg/kg) intravenously. The drugs, prepared in coded syringes, will be administered by an anesthetist blinded to group assignment. Shivering and hemodynamic variables were recorded. Sedation will be assessed by the Ramsay Sedation Score. Vomiting will be clinically monitored. If shivering reaches grade 3 or above, a rescue drug is given.
| Arm | Type | Receives |
|---|---|---|
| Participants assigned to this arm received injection nalbuphine. | Experimental | Drug: Participants assigned to this arm received injection nalbuphine.After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected in the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug Nalbuphin (0.07 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute. |
| Participants assigned to this arm received injection Ketamine. | Experimental | Drug: Participants assigned to this arm received injection ketamine.After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected into the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug ketamine (0.2 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female patients of age between 18 and 40 years undergoing gynecological surgeries (total abdominal hysterectomy, ovarian cystectomy, vaginal hysterectomy, myomectomy).
- ASA 1 and 2.
Key exclusion criteria (4 listed)
- ASA 3 and onwards as per the classification of the American Society of Anesthesiologists.
- Obstetric patients
- Patients who are allergic to study drugs.
- Patients undergoing general anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants assigned to this arm received injection nalbuphine.Also: Group NAfter spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected in the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug Nalbuphin (0.07 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute. | Drug | Participants assigned to this arm received injection nalbuphine. |
| Participants assigned to this arm received injection ketamine.Also: Group KAfter spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected into the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug ketamine (0.2 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute. | Drug | Participants assigned to this arm received injection Ketamine. |
Primary outcome
Incidence of shivering in both study groups
Time frame: Within one hour post-spinal anesthesia.
Shivering will be assessed by the presence or absence of shivering.
Grades of shivering
Time frame: After spinal anesthesia, grades of shivering were assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Shivering will be assessed by Tsai and Chu, with the grade of shivering as follows: Grade of shivering: clinical sign 0 No shivering 1. Piloerection or peripheral vasoconstriction, but no visible shivering 2. Muscular activity in only one muscle group 3. Muscular activity in more than one muscle group, but not generalized 4. Shivering involving the whole body
7 secondary outcomes
Heart rate
Time frame: After spinal anesthesia, heart rate will be assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Oxygen Saturation
Time frame: After spinal anesthesia, oxygen saturation was assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Systolic blood pressure
Time frame: After spinal anesthesia, systolic blood pressure was assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Diastolic blood pressure
Time frame: After spinal anesthesia, diastolic blood was assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Temperature
Time frame: After spinal anesthesia, temperature was assessed at 5 minutes and then after every 10 minutes until 60 minutes.
Sedation
Time frame: Sedation was assessed for 1 hour post spinal anaesthesia.
Vomiting
Time frame: Vomiting was assessed for one hour post spinal anesthesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. Your study is a single-center anesthesia comparison trial. There is no requirement to share individual participant data (IPD). Unless you have a formal data-sharing mechanism (repository, request process, timelines), selecting Yes will create extra mandatory fields.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants assigned to this arm received injection nalbuphine. and Participants assigned to this arm received injection ketamine. in people with Peri-operative Shivering Under Spinal Anaesthesia, run by Sargodha Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of shivering in both study groups (time frame: Within one hour post-spinal anesthesia.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.